Multiple Sclerosis Clinical Trial
— PRO-STEPOfficial title:
Protective Step Training in People With Multiple Sclerosis
Falls are common in Veterans with multiple sclerosis (MS), and current rehabilitation approaches to reduce falls are inadequate. Protective step training (in which a person is exposed to repeated "slips") is a promising tool to reduce falls in older adults. However, whether this approach is effective in people with MS is unknown. Investigating the effect of promising therapies, such as protective step training, will enhance our ability to treat Veterans with MS who are at risk for falls. Therefore, we will assess whether people with MS improve postural control and reduce falls through protective step training. we will also determine whether cognitive ability or brain structure can predict who will improve most. These data will inform clinical treatment strategies in people with MS at risk for falls.
Status | Recruiting |
Enrollment | 51 |
Est. completion date | July 24, 2024 |
Est. primary completion date | July 24, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - Neurologist diagnosed MS (for MS participants only) - Ability to Stand for 5 minutes without aid - Ability to comprehend English - At risk for falls (determined via questionnaire; for MS participants only) - EDMUS score <7 (determined by testers) Exclusion Criteria: - Any non-MS neurological pathology - Orthopedic impairments affecting balance - Previous cardiac events (stroke or heart attack) |
Country | Name | City | State |
---|---|---|---|
United States | Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Arizona State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Margin of Stability over training compared to change over baseline | Measure of stepping effectiveness; characterized as the difference between the extrapolated center of mass and the base of support at the instance of first foot contact. Large values represent better steps. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods. | Baseline 1, Baseline 2 (2 weeks after baseline 1), Post-test 1 (immediately after 2 week intervention) | |
Primary | Symbol Digit Modality Test | This cognitive assessment probes processing speed, is assessed via paper and pencil, and will be correlated to improvement in stepping through training. | Baseline 1 | |
Primary | Brain structural connectivity | Structural connectivity within the "locomotor region" will be assessed via diffusion tensor imaging and will be correlated to improvement in stepping through training | Baseline | |
Secondary | Change in Step Length over training period compared to change over baseline period | Length of first protective step. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods. | Baseline 1, Baseline 2 (2 weeks after baseline 1), Post-test 1 (immediately after 2 week intervention) | |
Secondary | Change in Step Latency (treadmill) over training period compared to change over baseline period | time from perturbation onset to step initiation. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods. | Baseline 1, Baseline 2 (2 weeks after baseline 1), Post-test 1 (immediately after 2 week intervention) |
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