Assistive Device Training in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Assistive Device Training
- Registration Number
- NCT02408718
- Lead Sponsor
- Portland VA Medical Center
- Brief Summary
The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.
- Detailed Description
40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program.
The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Multiple Sclerosis of any type,
- self-reported history of at least 1 fall in the previous year,
- able to walk at least 25 feet with or without an assistive device,
- clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment),
- intermittent or constant unilateral or bilateral assistance required to walk,
- right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.
- serious psychiatric or medical conditions that would preclude reliable participation in the study,
- dementia (MMSE <24),
- deafness,
- blindness,
- inability to follow directions in English,
- significant upper extremity tremor or weakness,
- more than 1 hour of assistive device training within the previous 3 years,
- any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training group Assistive Device Training Subjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device. They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later. During this time, their falls will be recorded monthly using prospective falls calendars. Members of this group will also receive MRI scans at baseline and after the completion of the training program.
- Primary Outcome Measures
Name Time Method Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training At baseline, 1 week after completion of training Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)
Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months At baseline, 1 week after completion of training, 3 months later Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12
Change from Baseline in Falls at Completion of Training and the Following Three Months First week of training, last week of training, 3 months later Change in rate of falls between time frames
- Secondary Outcome Measures
Name Time Method Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months At baseline, 1 week after completion of training, 3 months later Quebec User Evaluation of Satisfaction with Assistive Technologies
Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months At baseline, 1 week after completion of training, 3 months later Activities-specific Balance Confidence Questionnaire
Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months At baseline, 1 week after completion of training, 3 months later Multiple Sclerosis Impact Scale-29
Change from Baseline in Physical Activity at Completion of Training and the Following Three Months At baseline, 1 week after completion of training, 3 months later International Physical Activity Questionnaire
Trial Locations
- Locations (1)
VA Portland Health Care System
🇺🇸Portland, Oregon, United States