Facilitation Recovery For Patients With Chronic Stroke: The Q Therapeutic System, Frequency-Tuned Electromagnetic Field Treatment
Burke Rehabilitation Hospital
Summary
Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.
Description
This is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the management of chronic stroke patients. Primarily, the trial will assess the System's impact on the upper extremity function through objective, validated clinical assessments. Secondary endpoints will evaluate additional functional and global disability, quality-of-life and safety outcomes. The study intervention will consist of a total of 5 sessions per week over a period of 3 months (12 weeks) for a total of up to 6…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * FMA-UE score between 22-50 (inclusive) of impaired limb. * Difference between Screening and Baseline visit FMA-UE is 3 points or fewer. * Age 18 to 80 years of age (inclusive). * Stroke due to ischemia or to intracerebral hemorrhage. * \>6 months to 5 years from index stroke onset. * Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit. * Able to sit with the investigational System for 40 consecutive minutes. * Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent. * Willin…
Interventions
- DeviceQ Therapeutic System (BQ 3.0) - Active
The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery
Location
- Burke Rehabilitation HospitalWhite Plains, New York