Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
- Conditions
- Multiple SclerosisGait Disorders, NeurologicCognitive Impairment
- Interventions
- Other: Dual-task gaitOther: Single-task gait
- Registration Number
- NCT03536299
- Lead Sponsor
- Texas Woman's University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dual-Task Gait Dual-task gait The Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training. Single-Task Gait Single-task gait The Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks.
- Primary Outcome Measures
Name Time Method Change in Walking and Remembering Test 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 Outcome Measures
Name Time Method Change in 2-Minute Walk Test Week 1, Week 2, Week 5, Week 8, Week 12 Measures total distance walked by an individual within a 2-minute time period. Measures distance in feet and meters.
Change in Gait Speed Week 1, Week 2, Week 5, Week 8, Week 12 Changes in gait speed (m/s) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Change in Step Length Week 1, Week 2, Week 5, Week 8, Week 12 Changes in step length (cm) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Change in 12-Item Multiple Sclerosis Walking Scale Week 1, Week 2, Week 5, Week 8, Week 12 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 Gait Cadence Week 1, Week 2, Week 5, Week 8, Week 12 Changes in gait cadence (steps/min) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.
Change in Fatigue Scale for Motor and Cognitive Functions Week 1, Week 2, Week 5, Week 8, Week 12 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.
Trial Locations
- Locations (2)
TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen Center
🇺🇸Houston, Texas, United States
Texas Woman's University Institute of Health Sciences - Houston Center
🇺🇸Houston, Texas, United States