Q Therapeutic System for Chronic Stroke Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBurke Rehabilitation Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Q Therapeutic System (BQ 3.0) - Active
DeviceThe 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
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: BQ 3.0 Active Stimulation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment - Upper Extremity
a standardized, performance-based measure used to assess motor impairment in the upper limb following stroke or other neurological injuries
Time frame
Baseline, 3 month, 5 month, 6 monthSecondary outcomes
1
Box and Block Test
Timed test used to assess unilateral gross manual dexterity
Time frame
Baseline, 3 month, 5 month, 6 month2
Geriatric Depression Scale (Short Form) (GDS)
15-question self-administered questionnaire used to screen for depression in older adults. Each item is answered "Yes" or "No." One point is given for each answer that indicates depression (specific answers are predetermined). Score Range from 0-15. Interpretation: 0-4: Normal (no depression), 5-8: Mild depression, 9-11: Moderate Depression, 12-15: Severe Depression.
Time frame
Baseline, 3 month, 5 month, 6 month3
modified Rankin Scale (mRS)
Tool to assess the degree of disability or dependence in daily activities following a stroke or other neurological event. Scores range from 0 (no symptoms), 1 (no significant disability) to 6 (death), with increasing scores indicating greater levels of disability.
Time frame
Baseline, 3 month, 5 month, 6 month4
Stroke Impact Scale (SIS) Hand Domain
Assesses hand function through a self-report questionnaire with specific items focusing on how stroke has affected the individual's ability to use their hands in daily tasks. Each of the five items is rated on a 5-point scale from 1 (could not do at all) to 5 (not difficult at all), transformed to a 0-100 scale, where higher scores indicate better hand function. 0-19 (very severe difficulty or complete inability to use the hand), 20-39 (severe difficulty), 40-59 (moderate difficulty), 60-79 (mild difficulty), 80-100 (minimal or no difficulty with hand function).
Time frame
Baseline, 3 month, 5 month, 6 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Burke Rehabilitation Hospital
Lead sponsor
BrainQ Technologies Ltd.
Collaborator
Source ClinicalTrials.gov