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Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis (StraDiMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
StraDiMS implicit
StraDiMs explicit
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all participants: minimal cognitive function (MoCA ≥ 26)
  • Persons with MS:

    • Diagnosis of MS
    • EDSS 2.0 - 5.5
    • No relapse within the past 30 days.
    • Able to walk minimally 6 minutes consecutively and to step over the stepping platform without aid.

Exclusion Criteria:

  • Other medical conditions interfering with mobility.
  • Other neurological conditions.
  • Not able to understand instructions.
  • Major (unresolvable) problems with hearing or vision.

Sites / Locations

  • Noorderhart
  • National MS Center Melsbroek

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

MS group implicit

MS group explicit

HC group implicit (Healthy Controls)

HC group explicit (Healthy controls)

Arm Description

Outcomes

Primary Outcome Measures

Dual task (STEP + substraction sevens)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + substraction sevens)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + phonetic word list generation)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + phonetic word list generation)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + Auditory vigilance)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Dual task (STEP + Auditory vigilance)
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Dual Task (WALK + Subtraction sevens)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Dual Task (WALK + Subtraction sevens)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Dual Task (WALK + Word list generation (phonetic)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Dual Task (WALK + Word list generation (phonetic)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Dual Task (WALK + Auditory vigilance)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
Dual Task (WALK + Auditory vigilance)
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
learning measure
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. The outcome measure on this task is response time (time from the moment the tile lights up, until the participant steps on the tile).
fNIRS measure (functional near-infrared spectroscopy)
a block-design test with 3 tasks (cognitive ST, motor ST and DT) of 25 seconds per task-block (repeated 5 times) will be conducted with a functional near-infrared spectroscopy (fNIRS) neuroimaging system to measure hemoglobin changes during performance of the task and compared between single task and dual task conditions and between groups. Besides, fNIRS will be used during 1 task related to the learning-paradigm.

Secondary Outcome Measures

Age
height
weight
educational level questionnaire
date of diagnosis questionnaire
type of MS questionnaire
EDSS
Expanded Disability Status Scale (EDSS)
Digit span forwards visually
Brief Visuospatial Memory Test (BVMT)
10/36 Spatial Recall test (SPART)
Symbol Digit Modalities Test (SDMT)
Paced Auditory Serial Addition Test (PASAT)-3 seconds
Digit Span backwards auditory
6 minute walking test (6MWT)
Timed-Up and Go (TUG)
Timed 25 Foot Walk (T25FW)
4 square stepping test (FSST)
Berg Balance Scale (BBS)
Tandem Walk 3m
Motricity Index
Movement specific reinvestment scale (MSRS)
MS Neuropsychological screening questionnaire (MSNQ)
Multiple Sclerosis Walking Scale (MSWS-12)
Modified fatigue impact scale (MFIS)
Activities-specific Balance Confidence scale (ABC)
Dual Task Questionnaire (DTQ)

Full Information

First Posted
August 31, 2020
Last Updated
September 1, 2021
Sponsor
Hasselt University
Collaborators
National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt
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1. Study Identification

Unique Protocol Identification Number
NCT04538872
Brief Title
Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
Acronym
StraDiMS
Official Title
Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt

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
This study is a randomized controlled study in which we aim to include 60 persons with Multiple Sclerosis and 30 healthy controls. Two different learning strategies, an explicit and an implicit one, will be compared on effects on dual task performance. Further, clinical profile associated with these effects, and brain activity measured by functional near-infrared spectroscopy during dual tasking will be investigated. To this end, the study will cover 4 days: Day 1: examine clinical profile; Day 2: baseline dual task measures; Day 3: experimental learning paradigm with subjects randomly assigned to either the implicit or the explicit learning condition. Day 4: delayed retention dual task and fNIRS measures.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MS group implicit
Arm Type
Experimental
Arm Title
MS group explicit
Arm Type
Experimental
Arm Title
HC group implicit (Healthy Controls)
Arm Type
Active Comparator
Arm Title
HC group explicit (Healthy controls)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
StraDiMS implicit
Intervention Description
participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
Intervention Type
Behavioral
Intervention Name(s)
StraDiMs explicit
Intervention Description
participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
Primary Outcome Measure Information:
Title
Dual task (STEP + substraction sevens)
Description
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Time Frame
day 2
Title
Dual task (STEP + substraction sevens)
Description
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).
Time Frame
day 4
Title
Dual task (STEP + phonetic word list generation)
Description
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Time Frame
day 2
Title
Dual task (STEP + phonetic word list generation)
Description
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).
Time Frame
day 4
Title
Dual task (STEP + Auditory vigilance)
Description
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Time Frame
day 2
Title
Dual task (STEP + Auditory vigilance)
Description
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).
Time Frame
day 4
Title
Dual Task (WALK + Subtraction sevens)
Description
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Time Frame
day 2
Title
Dual Task (WALK + Subtraction sevens)
Description
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.
Time Frame
day 4
Title
Dual Task (WALK + Word list generation (phonetic)
Description
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Time Frame
day 2
Title
Dual Task (WALK + Word list generation (phonetic)
Description
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.
Time Frame
day 4
Title
Dual Task (WALK + Auditory vigilance)
Description
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
Time Frame
day 2
Title
Dual Task (WALK + Auditory vigilance)
Description
participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.
Time Frame
day 4
Title
learning measure
Description
participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. The outcome measure on this task is response time (time from the moment the tile lights up, until the participant steps on the tile).
Time Frame
Day 3
Title
fNIRS measure (functional near-infrared spectroscopy)
Description
a block-design test with 3 tasks (cognitive ST, motor ST and DT) of 25 seconds per task-block (repeated 5 times) will be conducted with a functional near-infrared spectroscopy (fNIRS) neuroimaging system to measure hemoglobin changes during performance of the task and compared between single task and dual task conditions and between groups. Besides, fNIRS will be used during 1 task related to the learning-paradigm.
Time Frame
day 4
Secondary Outcome Measure Information:
Title
Age
Time Frame
day 1
Title
height
Time Frame
day 1
Title
weight
Time Frame
day 1
Title
educational level questionnaire
Time Frame
day 1
Title
date of diagnosis questionnaire
Time Frame
day 1
Title
type of MS questionnaire
Time Frame
day 1
Title
EDSS
Description
Expanded Disability Status Scale (EDSS)
Time Frame
day 1
Title
Digit span forwards visually
Time Frame
day 1
Title
Brief Visuospatial Memory Test (BVMT)
Time Frame
day 1
Title
10/36 Spatial Recall test (SPART)
Time Frame
day 1
Title
Symbol Digit Modalities Test (SDMT)
Time Frame
day 1
Title
Paced Auditory Serial Addition Test (PASAT)-3 seconds
Time Frame
day 1
Title
Digit Span backwards auditory
Time Frame
day 1
Title
6 minute walking test (6MWT)
Time Frame
day 1
Title
Timed-Up and Go (TUG)
Time Frame
day 1
Title
Timed 25 Foot Walk (T25FW)
Time Frame
day 1
Title
4 square stepping test (FSST)
Time Frame
day 1
Title
Berg Balance Scale (BBS)
Time Frame
day 1
Title
Tandem Walk 3m
Time Frame
day 1
Title
Motricity Index
Time Frame
day 1
Title
Movement specific reinvestment scale (MSRS)
Time Frame
day 1
Title
MS Neuropsychological screening questionnaire (MSNQ)
Time Frame
day 1
Title
Multiple Sclerosis Walking Scale (MSWS-12)
Time Frame
day 1
Title
Modified fatigue impact scale (MFIS)
Time Frame
day 1
Title
Activities-specific Balance Confidence scale (ABC)
Time Frame
day 1
Title
Dual Task Questionnaire (DTQ)
Time Frame
day 1

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: all participants: minimal cognitive function (MoCA ≥ 26) Persons with MS: Diagnosis of MS EDSS 2.0 - 5.5 No relapse within the past 30 days. Able to walk minimally 6 minutes consecutively and to step over the stepping platform without aid. Exclusion Criteria: Other medical conditions interfering with mobility. Other neurological conditions. Not able to understand instructions. Major (unresolvable) problems with hearing or vision.
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
Renee Veldkamp, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Noorderhart
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
National MS Center Melsbroek
City
Steenokkerzeel
ZIP/Postal Code
1820
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis

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