Actively Recruiting
Q Therapeutic System for Chronic Stroke Recovery
Led by Burke Rehabilitation Hospital · Updated on 2025-08-12
25
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
Sponsors
B
Burke Rehabilitation Hospital
Lead Sponsor
B
BrainQ Technologies Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Q Therapeutic System for Chronic Stroke Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 22 and 50 on the impaired limb.
- Difference between Screening and Baseline FMA-UE scores is 3 points or fewer.
- Age between 18 and 80 years inclusive.
- Stroke caused by ischemia or intracerebral hemorrhage.
- Stroke occurred more than 6 months and less than 5 years ago.
- Box & Block Test score with affected arm is at least 1 block in 60 seconds at baseline.
- Able to sit with the investigational system for 40 consecutive minutes.
- Able to follow a 3-step command or a non-verbal equivalent.
- Willing to participate in physical exercises during study sessions.
- Has a relative or caregiver available to assist during treatment sessions and visits.
- If female, not pregnant, breastfeeding, or planning pregnancy during the study.
- Signed informed consent.
You will not qualify if you...
- Severe neglect impairing assessments or treatments.
- Severe depression with GDS score greater than 10 out of 15.
- Presence of MR-incompatible implanted devices or retained objects, or life-sustaining MR-compatible devices like pacemakers.
- Active epilepsy or anti-epileptic medication use for seizures, or seizures within last 5 years.
- Botulinum toxin treatment in the affected arm in the past 3 months or expected before 6-month visit.
- Severe upper extremity spasticity or contracture, or modified Ashworth Scale score of 3 or higher in biceps or pectoralis.
- Pre-existing neurological conditions that interfere with participation or evaluations.
- Significant visual disturbances that cannot be corrected and interfere with participation.
- Unstable serious illnesses or life expectancy less than 12 months.
- Alcohol or illicit drug abuse in past 6 months affecting participation.
- Participation in conflicting interventional trials.
- Participation in upper extremity rehabilitation within 4 weeks prior to screening or planned during study.
- Employee of the sponsor.
- Prisoner.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Actively Recruiting
Research Team
J
Josette Hartnett, MPH
CONTACT
A
Andrew Abdou, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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