PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study (NCT06336720) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
United States30 participantsStarted 2024-05-01
Plain-language summary
Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.
Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.
Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up.
Who can participate
Age range18 Years – 85 Years
SexALL
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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.