No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Burke Rehabilitation Hospital · Other
Who this trial is looking for
This trial is looking for people who have had a stroke and are experiencing difficulties with using their arms. Participants will try a new treatment for 3 months, which includes sessions both at a clinic and at home.
Are You a Good Fit for This Trial?
Must not be takingAnti-epileptic medication
Rules you outSevere neglect impairmentSevere UE spasticity
You may be able to join if
I am between 18 and 80 years old.
I have a certain level of arm function.
I had my stroke between 6 months and 5 years ago.
I can sit for 40 minutes.
I have someone to help me during the study.
I can follow simple commands.
I am willing to do physical exercises.
You may not be able to join if
I have severe depression.
I have serious visual problems that can't be fixed.
I have taken botulinum toxin in the last 3 months.
I have a serious illness with a life expectancy of less than 12 months.
I have participated in another trial that might conflict with this one.
I have used alcohol or drugs in the past 6 months that could affect my ability to participate.
I have a severe neurological condition like Alzheimer's or Parkinson's.
I am a prisoner.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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 o…
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.
* Willingness to participate in physical exercises during study intervention sessions.
* Availability of a relative or other caregiver able to assist during study treatment sessions and visits.
* If female, not pregnant or breastfeeding or planning pregnancy during the study period.
* Informed consent signed by subject.
Exclusion Criteria:
* Severe neglect impairment interfering with assessments or treatments.
* Severe depression, defined as GDS Score \>10/15
* The presence of MR-incompatible implanted devices or MR-incompatible retained objects; or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).
* Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years
* Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
* Severe UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
* Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
* Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
* Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
* Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
* Participation in another interventional trial that would conflict with the current study or clinical endpoint interference may occur.
* Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.
* Employee of the Sponsor.
* Prisoner.
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