Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis, Gait Disorders, Neurologic, Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual-task gait
Single-task gait
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Physical therapy, Gait training, Cognitive-motor interference, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Ability walk independently with or without an assistive device
- Independent and community-dwelling
- No history or presence of other clinically significant musculoskeletal, cardiovascular, respiratory, or neurologic disease.
- Definite diagnosis of MS [Expanded Disability Status Scale (EDSS) ≤6.5]
- Relapse free for the past 30 days and not currently receiving or will receive any rehabilitation services during the study.
Exclusion Criteria:
- Participants experiencing a true relapse or exacerbation of their symptoms (>24 hours duration in the absence infection or fever, or and ambient increase in body temperature) during the study will be excluded from the study.
Sites / Locations
- Texas Woman's University Institute of Health Sciences - Houston CenterRecruiting
- TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single-Task Gait
Dual-Task Gait
Arm Description
The Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks.
The Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training.
Outcomes
Primary Outcome Measures
Change in Walking and Remembering Test
Measures dual-task cost of gait and a titrated forward digit span cognitive task, measured as a percentage.
Secondary Outcome Measures
Change in 2-Minute Walk Test
Measures total distance walked by an individual within a 2-minute time period. Measures distance in feet and meters.
Change in 12-Item Multiple Sclerosis Walking Scale
Measures self-reported and self-perceived walking disability due to MS in the past 2 weeks. The 12-Item Multiple Sclerosis Walking Scale consists of 12 questions. Each question is rated on a Likert scale from 1 (not at all) to 5 (extremely). The items are scored for a minimum score possible of 12 or a maximal score of 60. This summed score is then divided by 60 and the resulting percentage is interpreted. The scale's final percentage score can range from a minimum of 20% (minimal impact of MS on walking, good outcome) to a maximum of 100% (significant impact of MS on walking, poor outcome).
Change in Fatigue Scale for Motor and Cognitive Functions
Measures self-reported physical and mental fatigue levels by the patient with MS. The Fatigue Scale for Motor and Cognitive Functions measures both the motor and cognitive domains of fatigue. The scale consists of 20 total items: 10 items related to motor fatigue and 10 items related to cognitive fatigue. Each item is rated on a Likert scale from 1 (does not apply at all) to 5 (applies completely). The scale items can be summed for a total score (ranging from 20 to 100) or subscales can be summed and interpreted with each subscale ranging from a minimum of 10 points to a maximal 50 points. Higher values in the total score or in the subscale scores indicate worse fatigue and poorer quality of life due to fatigue.
Change in Gait Speed
Changes in gait speed (m/s) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Change in Gait Cadence
Changes in gait cadence (steps/min) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Change in Step Length
Changes in step length (cm) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Full Information
NCT ID
NCT03536299
First Posted
May 2, 2018
Last Updated
September 17, 2019
Sponsor
Texas Woman's University
Collaborators
TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03536299
Brief Title
Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
Acronym
MS
Official Title
Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Woman's University
Collaborators
TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
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
The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.
Detailed Description
A total target sample size of 40 adults with MS and 40 adults without MS will be recruited. The 40 adults without MS will undergo the two baseline testing sessions only for the first phase of the study. 20 of those individuals with MS will be randomly selected to undergo the intervention phase of the study.
The research design will include two groups, the intervention and control group. Both groups will undergo a screening process, two baseline testing sessions, and be randomly assigned to one of the two groups. The duration of the study is 6 weeks in length for a total of 18 training sessions. The intervention group participants will undergo gait training with a specific concomitant cognitive task (dual-task) for a total walking time of 20 minutes and with rest breaks the total session time is ~60 minutes with a physical therapist. The control group will undergo gait training, but without the cognitive task. Feedback from the therapist will be provided to each participant concerning gait mechanics and ways to improve gait regardless of group membership.
Outcome measures data will be collected twice at baseline, once at mid-intervention, once at post-intervention, and once at one-month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Gait Disorders, Neurologic, Cognitive Impairment
Keywords
Physical therapy, Gait training, Cognitive-motor interference, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single-Task Gait
Arm Type
Active Comparator
Arm Description
The Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks.
Arm Title
Dual-Task Gait
Arm Type
Experimental
Arm Description
The Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training.
Intervention Type
Other
Intervention Name(s)
Dual-task gait
Intervention Description
During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. In addition to performing the gait training activities, you will be asked to perform thinking tasks at the same time. These pre-recorded questions or prompts will be provided to you through headphones and a portable music player. This is to help ensure that the PT is able to focus on giving you feedback about your walking ability and answers to the thinking tasks, and on your safety. At the end of each session, you will have walked for a total walking time of 20 minutes.
Intervention Type
Other
Intervention Name(s)
Single-task gait
Intervention Description
During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. At the end of each session, you will have walked for a total walking time of 20 minutes.
Primary Outcome Measure Information:
Title
Change in Walking and Remembering Test
Description
Measures dual-task cost of gait and a titrated forward digit span cognitive task, measured as a percentage.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Secondary Outcome Measure Information:
Title
Change in 2-Minute Walk Test
Description
Measures total distance walked by an individual within a 2-minute time period. Measures distance in feet and meters.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Title
Change in 12-Item Multiple Sclerosis Walking Scale
Description
Measures self-reported and self-perceived walking disability due to MS in the past 2 weeks. The 12-Item Multiple Sclerosis Walking Scale consists of 12 questions. Each question is rated on a Likert scale from 1 (not at all) to 5 (extremely). The items are scored for a minimum score possible of 12 or a maximal score of 60. This summed score is then divided by 60 and the resulting percentage is interpreted. The scale's final percentage score can range from a minimum of 20% (minimal impact of MS on walking, good outcome) to a maximum of 100% (significant impact of MS on walking, poor outcome).
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Title
Change in Fatigue Scale for Motor and Cognitive Functions
Description
Measures self-reported physical and mental fatigue levels by the patient with MS. The Fatigue Scale for Motor and Cognitive Functions measures both the motor and cognitive domains of fatigue. The scale consists of 20 total items: 10 items related to motor fatigue and 10 items related to cognitive fatigue. Each item is rated on a Likert scale from 1 (does not apply at all) to 5 (applies completely). The scale items can be summed for a total score (ranging from 20 to 100) or subscales can be summed and interpreted with each subscale ranging from a minimum of 10 points to a maximal 50 points. Higher values in the total score or in the subscale scores indicate worse fatigue and poorer quality of life due to fatigue.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Title
Change in Gait Speed
Description
Changes in gait speed (m/s) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Title
Change in Gait Cadence
Description
Changes in gait cadence (steps/min) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Title
Change in Step Length
Description
Changes in step length (cm) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Other Pre-specified Outcome Measures:
Title
Changes in Visual Analog Scale for Fatigue
Description
The visual analog scale for fatigue measures immediate self-reported fatigue. This scale is commonly used to monitor and individual's fatigue level to ensure his or her safety during an activity. The individual marks his or her fatigue level on a 10-cm line with one end denoting "no fatigue" and the opposite end denoting "very severe fatigue". The individual's fatigue level is them measured in cm.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
Title
Changes in Borg Rating of Perceived Exertion
Description
The Borg Rating of Perceived Exertion is a self-reported scale that measures how much exertion an individual is putting forth during a physical activity. It ranges from 6 (no exertion) to 20 (maximal exertion). The individual chooses a number between 6 and 20 to represent his or her level of exertion. This is commonly used to monitor an individual to ensure that he or she is exercising or performing within a safe level.
Time Frame
Week 1, Week 2, Week 5, Week 8, Week 12
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:
Ability walk independently with or without an assistive device
Independent and community-dwelling
No history or presence of other clinically significant musculoskeletal, cardiovascular, respiratory, or neurologic disease.
Definite diagnosis of MS [Expanded Disability Status Scale (EDSS) ≤6.5]
Relapse free for the past 30 days and not currently receiving or will receive any rehabilitation services during the study.
Exclusion Criteria:
- Participants experiencing a true relapse or exacerbation of their symptoms (>24 hours duration in the absence infection or fever, or and ambient increase in body temperature) during the study will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory A Brusola, PT,DPT,MSCS
Phone
940-268-3482
Email
gregory.brusola@memorialhermann.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katy Mitchell, PT, PhD
Phone
713-794-2070
Email
kmitchell@twu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Brusola, PT,DPT,MSCS
Organizational Affiliation
Texas Woman's University & TIRR Memorial Hermann
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University Institute of Health Sciences - Houston Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory A Brusola, PT,DPT,MSCS
Phone
940-268-3482
Email
gregory.brusola@memorialhermann.org
Facility Name
TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory A Brusola, PT,DPT,MSCS
Phone
940-268-3482
Email
gregory.brusola@memorialhermann.org
First Name & Middle Initial & Last Name & Degree
Marissa Lyon, PT, DPT
First Name & Middle Initial & Last Name & Degree
Daniel Wingard, PT, DPT
12. IPD Sharing Statement
Plan to Share IPD
No
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Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
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