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.
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.
Study Type
OBSERVATIONAL
Enrollment
43
The PoNS device used in conjunction with rehabilitative physical therapy
Shepherd Center
Atlanta, Georgia, United States
MGH Institute of Health Professions
Boston, Massachusetts, United States
Neurology Center of New England, P.C.
Foxborough, Massachusetts, United States
NYU Langone Health, NYU Grossman School of Medicine
New York, New York, United States
Measure subjects' adherence to PoNS therapy (device + physical therapy)
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).
Time frame: 14 weeks
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
a. subject's improvement of gait as measured by the Timed 25-foot Walk Test
Time frame: 14 weeks
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
b. balance deficits as measured by the Timed Up and Go Cognitive (TUG-Cog) Test,
Time frame: 14 weeks
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
c. investigator's impression of clinical improvement as measured by the Clinical Global Impression (CGI)
Time frame: 14 weeks
Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
a. the rate and timing of investigator initiated second course of therapy
Time frame: 14 weeks
Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
b. the magnitudes of improvements in gait and balance deficits during the second course of therapy
Time frame: 14 weeks
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Oregon Health and Science university (OHSU)
Portland, Oregon, United States
3) Association between likelihood of second course of therapy and magnitudes of improvement with adherence during the initial therapy
adherence during the second course of therapy, and changes in adherence
Time frame: 14 weeks