Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)
Conditions
Keywords
Gait, rehabilitation, PoNS, device, therapy, adherence, outcome
Brief summary
PoNS therapy is a rehabilitation program that uses the PoNS device in conjunction with individualized physical exercise. This is an outcome research open label observational interventional multi-center study investigating the relationship between subject's adherence to PoNS therapy and therapeutic outcomes.
Detailed description
Study participants will undergo fourteen weeks of on-label PoNS therapy and, specifically, two weeks in-clinic PoNS therapy directly supervised by a physical therapist who has been trained on PoNS therapy by Helius Medical and certified as a clinic PoNS trainer (Phase 1) followed by 12 weeks of at-home unsupervised PoNS therapy Once weekly in-clinic PoNS therapy session (Phase 2). Subjects will be then asked to return to the clinic six month after the end of the study Phase 2 to assess maintenance of PoNS therapy effects.
Interventions
DEVICEPoNS®
The PoNS device used in conjunction with rehabilitative physical therapy
Sponsors
Helius Medical Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women ≥ 22 years of age with a diagnosis of MS. 2. EDSS scores \< 6.5 at screening; a demonstrated gait deficit. 3. Can walk at least 10 meters with or without the use of walking aids. 4. Participants must be stable without relapse for at least 60 days and agree to PoNS therapy regimen.
Exclusion criteria
1. Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait. 2. Dementia. 3. Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen. 4. Subjects who are already functional community ambulators (gait speed\>120cm/s43). 5. Subjects will also be excluded as per the Helius Medical PoNS device indication for usage (electrical stimulation should not be used: if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; in areas that lack normal sensation; in women who are pregnant, or in people with sensitivity to nickel, gold or copper).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure subjects' adherence to PoNS therapy (device + physical therapy) | 14 weeks | Subjects' adherence to at-home PoNS therapy (device + physical therapy) over 12 weeks following 2 weeks of supervised PoNS therapy at a physical therapy clinic and the relationship between subject's therapy adherence behavior and therapeutic functional outcomes as measured by the Dynamic Gait Index (DGI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating | 14 weeks | a. subject's improvement of gait as measured by the Timed 25-foot Walk Test |
| Clinical improvement among subjects receiving a second course of PoNS therapy as measured by: | 14 weeks | a. the rate and timing of investigator initiated second course of therapy |
| 3) Association between likelihood of second course of therapy and magnitudes of improvement with adherence during the initial therapy | 14 weeks | adherence during the second course of therapy, and changes in adherence |
Countries
United States
Outcome results
None listed