Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Texas Woman's University
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Change in Walking and Remembering Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Single-Task Gait
The Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks.
Intervention: Single-task gait (Other)
Dual-Task Gait
The Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training.
Intervention: Dual-task gait (Other)
Outcomes
Primary Outcomes
Change in Walking and Remembering Test
Time Frame: Week 1, Week 2, Week 5, Week 8, Week 12
Measures dual-task cost of gait and a titrated forward digit span cognitive task, measured as a percentage.
Secondary Outcomes
- Change in 2-Minute Walk Test(Week 1, Week 2, Week 5, Week 8, Week 12)
- Change in Gait Speed(Week 1, Week 2, Week 5, Week 8, Week 12)
- Change in Step Length(Week 1, Week 2, Week 5, Week 8, Week 12)
- Change in 12-Item Multiple Sclerosis Walking Scale(Week 1, Week 2, Week 5, Week 8, Week 12)
- Change in Gait Cadence(Week 1, Week 2, Week 5, Week 8, Week 12)
- Change in Fatigue Scale for Motor and Cognitive Functions(Week 1, Week 2, Week 5, Week 8, Week 12)