Cognitive-motor Interference in Persons With MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dual Task Training
Single Mobility Training
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of MS according to McDonald criteria
- EDSS ≥2 and ≤ 6
- No relapse within the last 30 days
- No changes in disease modifying treatment and no corticoid-therapy within the last 50 days
- All types of MS
- Minimal cognitive functioning (MMSE≥26)
- Presence of dual task interference (dual task screening list ≥1)
Exclusion Criteria:
- Other medical conditions interfering with mobility
- Other neurological diagnoses
- MS-like syndroms such as neruomyelitis optica
- Not able to understand and execute simple instructions
- Problems (even after adjustment with hearing aids or glasses) with hearing or vision interfering with the assessment or training.
- Ongoing dual task training or other interfering physical therapy or cognitive training/neuropsychological rehabilitation.
Sites / Locations
- Revalidatie & MS Centrum Overpelt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual Task Training (DTT)
Single Mobility Training (SMT)
Arm Description
Outcomes
Primary Outcome Measures
Digit Span - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1
Digit Span - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1
Digit Span - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1
Subtraction - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.)
Subtraction - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.)
Subtraction - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.)
Vigilance - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Vigilance - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Vigilance - Walk - Dual Task Cost (%)
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Digit Span - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Digit Span - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Digit Span - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Subtraction - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Subtraction - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 ->145 - 138 - 131, etc.).
Subtraction - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Vigilance - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard
Vigilance - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard
Vigilance - Cup - Dual Task Cost (%)
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard
Digit Span - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Digit Span - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Digit Span - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Subtraction - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Subtraction - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 ->145 - 138 - 131, etc.).
Subtraction - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Vigilance - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Vigilance - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Vigilance - Obstacles - Dual Task Cost (%)
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Digit Span - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Digit Span - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Digit Span - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Subtraction - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Subtraction - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Subtraction - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Vigilance - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Vigilance - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Vigilance - Crisscross - Dual Task Cost (%)
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Secondary Outcome Measures
Brief Repeatable Battery of Neuropsychological Tests
This battery consists of six tests in different cognitive domains: 1) the Selective Reminding test, 2) the 10/36 spatial recall test, 3) the symbol digit modalities test, 4) the Paced auditory serial addition test with 3 seconds, 5) the Paced auditory serial addition test with 2 seconds and 6) the word list generation.
Part of Brief Repeatable Battery of Neuropsychological Tests
The symbol digit modalities test, the Paced auditory serial addition test with 3 seconds and the Paced auditory serial addition test with 2 seconds were assessed.
Part of Brief Repeatable Battery of Neuropsychological Tests
The symbol digit modalities test, the Paced auditory serial addition test with 3 seconds and the Paced auditory serial addition test with 2 seconds were assessed.
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Modified Fatigue Impact Scale (MFIS)
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Modified Fatigue Impact Scale (MFIS)
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Modified Fatigue Impact Scale (MFIS)
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Dual Task Questionnaire
Questionnaire to record participants' perception of dual task problems in daily life.
Dual Task Questionnaire
Questionnaire to record participants' perception of dual task problems in daily life.
Dual Task Questionnaire
Questionnaire to record participants' perception of dual task problems in daily life.
Timed 25 Foot-walk test (T25FW)
test of motor function in which participants walk 25-foot.
Timed 25 Foot-walk test (T25FW)
test of motor function in which participants walk 25-foot.
Timed 25 Foot-walk test (T25FW)
test of motor function in which participants walk 25-foot.
Timed-up-and-go test (TUG)
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Timed-up-and-go test (TUG)
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Timed-up-and-go test (TUG)
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Dynamic Gait Index (DGI)
test in which assessor scores gait performance of the participant.
Dynamic Gait Index (DGI)
test in which assessor scores gait performance of the participant.
Dynamic Gait Index (DGI)
test in which assessor scores gait performance of the participant.
2-minute walking test (2MWT)
test of walking in which participants walk for 2 minutes
2-minute walking test (2MWT)
test of walking in which participants walk for 2 minutes
2-minute walking test (2MWT)
test of walking in which participants walk for 2 minutes
Multiple sclerosis walking scale-12 (MSWS-12)
questionnaire to measure perception of limitations in walking ability caused by MS.
Multiple sclerosis walking scale-12 (MSWS-12)
questionnaire to measure perception of limitations in walking ability caused by MS.
Multiple sclerosis walking scale-12 (MSWS-12)
questionnaire to measure perception of limitations in walking ability caused by MS.
Falls efficacy scale (FES-I)
uestionnaire to measure concerns about the possibility of falling.
Falls efficacy scale (FES-I)
uestionnaire to measure concerns about the possibility of falling.
Falls efficacy scale (FES-I)
uestionnaire to measure concerns about the possibility of falling.
Full Information
NCT ID
NCT04158063
First Posted
November 6, 2019
Last Updated
November 8, 2019
Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek, AZ Klina, Centre Hospitalier Universitaire de Liege, Masku Neurological Rehabilitation Centre, Tel Aviv University, Sheba Medical Center, AISM Rehabilitation Service of Genoa
1. Study Identification
Unique Protocol Identification Number
NCT04158063
Brief Title
Cognitive-motor Interference in Persons With MS
Official Title
Cognitive-motor Interference in Persons With MS: Dual Task Assessment and Training - A Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek, AZ Klina, Centre Hospitalier Universitaire de Liege, Masku Neurological Rehabilitation Centre, Tel Aviv University, Sheba Medical Center, AISM Rehabilitation Service of Genoa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dual tasking such as walking while talking on the phone or while remembering a shopping list is very frequently required in everyday life. Cognitive-motor interference occurs when the performance capacity of a motor or cognitive task decreases when both are performed simultaneously (dual task) compared to single task execution being the so-called dual task cost (DTC). Over the past five years, in MS, (pilot) studies have been conducted in order to investigate the presence and magnitude of the CMI during walking. It was shown that, even in the early stages of the disease, when walking speed is not affected as a single motor task, pwMS slow down more than healthy controls when performing DT walking. Studies have not yet investigated the impact of the complexity of the motor task, on the DTC. Across studies, many different types of cognitive distractors were applied without any documentation of psychometric properties, such as test-retest reliability, making it not yet suited as experimental outcome measure. Results have also focused on the effects of DT on walking performance, while the performance of the cognitive task was rarely assessed. Also, the majority of studies did not document the cognitive function level of pwMS or even excluded patients with cognitive deficits. As such, the relation between cognitive deficits and dual task (cognitive-motor) performance is unclear.
Motor and cognitive impairment are currently also treated separately whereas real life performance very often requiring an integrated motor and cognitive function. So far, no studies in MS have investigated the effects of physical or cognitive exercises on DT performances, or investigated effects of integrated cognitive-motor dual task training (DTT). In elderly and other neurological conditions, superior effects of dual task training (DTT) on gait training have been suggested, but the evidence is not robust yet. All these studies suggest the feasibility of DTT on gait improvement and fall risk reduction, but further insights on factors identifying responders, and differential effect of cognitive distractors needs further elucidation.
This research consist of two parts that aim to investigate:
Part 1: Assessment
the magnitude of the dual task cost according to different types of cognitive distractors (information processing, memory, attention, etc.),
its reliability as experimental outcome measure and
its association with factors as severity of cognitive or motor dysfunction, quality of life and fatigue.
Part 2: Intervention
the effectiveness of cognitive-motor DT-based training programs compared to single modality training, on DT and ST performances (cognition and mobility)
whether dual task learning effects transfer to improvements in daily life and are sustained for 4 weeks without training
which patient profiles benefit most from the integrated cognitive-motor training
feasibility and usefulness of an adaptive, interactive ICT-guided DTT system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
knows what kind of training, but not whether the trainings-group is the control group
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dual Task Training (DTT)
Arm Type
Experimental
Arm Title
Single Mobility Training (SMT)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Dual Task Training
Intervention Description
In total 12 Dual Task conditions will be performed in which 3 cognitive tasks are combined with 4 motor tasks:
Cognitive tasks:
Titrated digit span backwards
Auditory vigilance with alphabets
Subtracting by 7
Motor tasks:
Walking at self-selected speed
Walking while carrying a cup of water
Walking while stepping over obstacles
Walking crisscross
Intervention Type
Other
Intervention Name(s)
Single Mobility Training
Intervention Description
standard routine training
Primary Outcome Measure Information:
Title
Digit Span - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1
Time Frame
Baseline
Title
Digit Span - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1
Time Frame
Week 9 (post-measure)
Title
Digit Span - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 - 5 4 1
Time Frame
week 13 (4-week follow-up)
Title
Subtraction - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.)
Time Frame
Baseline
Title
Subtraction - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.)
Time Frame
Week 9 (post-measure)
Title
Subtraction - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.)
Time Frame
week 13 (4-week follow-up)
Title
Vigilance - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
Baseline
Title
Vigilance - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
Week 9 (post-measure)
Title
Vigilance - Walk - Dual Task Cost (%)
Description
persons walked at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
week 13 (4-week follow-up)
Title
Digit Span - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
Baseline
Title
Digit Span - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
Week 9 (post-measure)
Title
Digit Span - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
week 13 (4-week follow-up)
Title
Subtraction - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Time Frame
Baseline
Title
Subtraction - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 ->145 - 138 - 131, etc.).
Time Frame
Week 9 (post-measure)
Title
Subtraction - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Time Frame
week 13 (4-week follow-up)
Title
Vigilance - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard
Time Frame
baseline
Title
Vigilance - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard
Time Frame
Week 9 (post-measure)
Title
Vigilance - Cup - Dual Task Cost (%)
Description
persons walked at self-selected speed with a cup filled with water in the hand on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard
Time Frame
week 13 (4-week follow-up)
Title
Digit Span - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
Baseline
Title
Digit Span - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
Week 9 (post-measure)
Title
Digit Span - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
week 13 (4-week follow-up)
Title
Subtraction - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Time Frame
Baseline
Title
Subtraction - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 ->145 - 138 - 131, etc.).
Time Frame
Week 9 (post-measure)
Title
Subtraction - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Time Frame
week 13 (4-week follow-up)
Title
Vigilance - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
Baseline
Title
Vigilance - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
Week 9 (post-measure)
Title
Vigilance - Obstacles - Dual Task Cost (%)
Description
persons walked at self-selected speed while stepping over obstacles placed every 3 meters on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
week 13 (4-week follow-up)
Title
Digit Span - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
baseline
Title
Digit Span - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
Week 9 (post-measure)
Title
Digit Span - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the titrated digit span backwards. The titrated digit span backward is a task in which the participant hears a string of numbers that they have to repeat in reverse order (f.e. 1 4 5 -> 5 4 1).
Time Frame
week 13 (4-week follow-up)
Title
Subtraction - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Time Frame
Baseline
Title
Subtraction - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Time Frame
Week 9 (post-measure)
Title
Subtraction - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the serial subtraction with sevens task. The serial subtraction with sevens task is a task in which the participant was given a starting number of 3 digits (e.g. 152) from which they had to continuously subtract sevens (f.e. 152 -> 145 - 138 - 131, etc.).
Time Frame
week 13 (4-week follow-up)
Title
Vigilance - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
Baseline
Title
Vigilance - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
Week 9 (post-measure)
Title
Vigilance - Crisscross - Dual Task Cost (%)
Description
persons walked crisscross from cone to cone every 2m with 80cm fixed width in between at self-selected speed on a 30-meter walkway for 1 minute, while performing the vigilance task. The vigilance task is a task in which the participants listened to letters of the alphabet and had to say aloud 'yes' every time they heard 1 of the 2 target letters (e.g. 'L' or 'R') and were asked not to respond when another letter was heard.
Time Frame
week 13 (4-week follow-up)
Secondary Outcome Measure Information:
Title
Brief Repeatable Battery of Neuropsychological Tests
Description
This battery consists of six tests in different cognitive domains: 1) the Selective Reminding test, 2) the 10/36 spatial recall test, 3) the symbol digit modalities test, 4) the Paced auditory serial addition test with 3 seconds, 5) the Paced auditory serial addition test with 2 seconds and 6) the word list generation.
Time Frame
baseline
Title
Part of Brief Repeatable Battery of Neuropsychological Tests
Description
The symbol digit modalities test, the Paced auditory serial addition test with 3 seconds and the Paced auditory serial addition test with 2 seconds were assessed.
Time Frame
Week 9 (post-measure)
Title
Part of Brief Repeatable Battery of Neuropsychological Tests
Description
The symbol digit modalities test, the Paced auditory serial addition test with 3 seconds and the Paced auditory serial addition test with 2 seconds were assessed.
Time Frame
week 13 (4-week follow-up)
Title
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Description
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Time Frame
baseline
Title
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Description
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Time Frame
Week 9 (post-measure)
Title
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Description
Questionnaire to record participants' perceived impact of MS on day-to-day life.
a 29-item self-report measure comprised of 20 items associated with a physical scale and 9 items associated with a psychological scale.1 Items question patients (or their proxies) about the impact of multiple sclerosis (MS) on day-today life in the last 2 weeks. All items have 5 response options from 1 (not at all) to 5 (extremely). Each of the 2 scales are scored by summing the responses across items, then converting to a 0 to 100 scale, where 100 indicates greater impact of disease on daily function (worse health).
Time Frame
week 13 (4-week follow-up)
Title
Modified Fatigue Impact Scale (MFIS)
Description
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Time Frame
baseline
Title
Modified Fatigue Impact Scale (MFIS)
Description
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Time Frame
Week 9 (post-measure)
Title
Modified Fatigue Impact Scale (MFIS)
Description
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
Time Frame
week 13 (4-week follow-up)
Title
Dual Task Questionnaire
Description
Questionnaire to record participants' perception of dual task problems in daily life.
Time Frame
Baseline
Title
Dual Task Questionnaire
Description
Questionnaire to record participants' perception of dual task problems in daily life.
Time Frame
Week 9 (post-measure)
Title
Dual Task Questionnaire
Description
Questionnaire to record participants' perception of dual task problems in daily life.
Time Frame
week 13 (4-week follow-up)
Title
Timed 25 Foot-walk test (T25FW)
Description
test of motor function in which participants walk 25-foot.
Time Frame
baseline
Title
Timed 25 Foot-walk test (T25FW)
Description
test of motor function in which participants walk 25-foot.
Time Frame
Week 9 (post-measure)
Title
Timed 25 Foot-walk test (T25FW)
Description
test of motor function in which participants walk 25-foot.
Time Frame
week 13 (4-week follow-up)
Title
Timed-up-and-go test (TUG)
Description
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Time Frame
baseline
Title
Timed-up-and-go test (TUG)
Description
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Time Frame
Week 9 (post-measure)
Title
Timed-up-and-go test (TUG)
Description
test of walking and balance in which participants stand up from a chair, walk, turn and sit down again.
Time Frame
week 13 (4-week follow-up)
Title
Dynamic Gait Index (DGI)
Description
test in which assessor scores gait performance of the participant.
Time Frame
Baseline
Title
Dynamic Gait Index (DGI)
Description
test in which assessor scores gait performance of the participant.
Time Frame
Week 9 (post-measure)
Title
Dynamic Gait Index (DGI)
Description
test in which assessor scores gait performance of the participant.
Time Frame
week 13 (4-week follow-up)
Title
2-minute walking test (2MWT)
Description
test of walking in which participants walk for 2 minutes
Time Frame
baseline
Title
2-minute walking test (2MWT)
Description
test of walking in which participants walk for 2 minutes
Time Frame
Week 9 (post-measure)
Title
2-minute walking test (2MWT)
Description
test of walking in which participants walk for 2 minutes
Time Frame
week 13 (4-week follow-up)
Title
Multiple sclerosis walking scale-12 (MSWS-12)
Description
questionnaire to measure perception of limitations in walking ability caused by MS.
Time Frame
baseline
Title
Multiple sclerosis walking scale-12 (MSWS-12)
Description
questionnaire to measure perception of limitations in walking ability caused by MS.
Time Frame
Week 9 (post-measure)
Title
Multiple sclerosis walking scale-12 (MSWS-12)
Description
questionnaire to measure perception of limitations in walking ability caused by MS.
Time Frame
week 13 (4-week follow-up)
Title
Falls efficacy scale (FES-I)
Description
uestionnaire to measure concerns about the possibility of falling.
Time Frame
baseline
Title
Falls efficacy scale (FES-I)
Description
uestionnaire to measure concerns about the possibility of falling.
Time Frame
Week 9 (post-measure)
Title
Falls efficacy scale (FES-I)
Description
uestionnaire to measure concerns about the possibility of falling.
Time Frame
week 13 (4-week follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of MS according to McDonald criteria
EDSS ≥2 and ≤ 6
No relapse within the last 30 days
No changes in disease modifying treatment and no corticoid-therapy within the last 50 days
All types of MS
Minimal cognitive functioning (MMSE≥26)
Presence of dual task interference (dual task screening list ≥1)
Exclusion Criteria:
Other medical conditions interfering with mobility
Other neurological diagnoses
MS-like syndroms such as neruomyelitis optica
Not able to understand and execute simple instructions
Problems (even after adjustment with hearing aids or glasses) with hearing or vision interfering with the assessment or training.
Ongoing dual task training or other interfering physical therapy or cognitive training/neuropsychological rehabilitation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilse Baert, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Renee Veldkamp, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Revalidatie & MS Centrum Overpelt
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Cognitive-motor Interference in Persons With MS
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