Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stro… (NCT06470009) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Randomized Controlled Trial.
Canada60 participantsStarted 2024-06-12
Plain-language summary
Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men and women ≥ 18 and \< 85 years of age with a diagnosis ischemic or hemorrhagic stroke at \> 6 months since stroke onset event.
✓. FMA-LE scores \< 34 at screening with residual paresis in the lower extremity.
✓. Able to walk at least 10 feet with or without assistive device.
✓. FGA score \< 23 at screening.
✓. Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6
✓. Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program.
Exclusion criteria
✕. Pre-existing neurological disorders or previous stroke affecting the other hemisphere.
✕. Severe arthritis or orthopedic problems that limit passive range of motion.
✕. Areas of recent bleeding or open wounds; or areas that lack normal sensation on the tongue.
✕. Diagnosis of dementia or mild cognitive impairment
✕. Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other peripheral stimulation devices (i.e. Bioness®)
✕. Neurostimulation therapy over the previous 6 months