This trial will test a promising new intervention to promote post-stroke neural reorganization and functional recovery. The overall aim is to identify a systematic, methodological approach to system fitting, training protocols, and optimization of collecting outcome measures. Aim 1: Assess the safety of using the Q Therapeutic (BQ 3.0) System, including in-clinic and at- extremity rehabilitation training for individuals with chronic stroke, as determined by the number of adverse events. Device deficiencies will also be recorded to detect operational reliability. Aim 2: 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.
STUDY DESIGN: * 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. * While this trial is conducted as a single-center Investigator-Initiated Trial (IIT), additional sites have initiated comparable IITs following a similar trial design. These sites will adhere to the core aspects of the study, with a prospective intent to pool results across sites into a primary pooled analysis, following a formal statistical plan. * All enrolled participants will undergo treatment with the investigational device according to the defined study protocol. * 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. * As a single-arm study, all participants will serve as their own control, with baseline measurements collected prior to device intervention and compared to post-treatment outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Device: Q 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.
Mean change of FMA-UE score
Mean change of FMA-UE score from Baseline to the 3-months follow-up visit. A performance measure used to assess arm function. 33 items are scored on a scale of 0 to 2, where 0=cannot perform, 1=performs partially and 2=performs fully. An increase in score reflects an improvement in arm function.
Time frame: Baseline, 3 months after, and 6 months after start of interventions
Safety endpoints: Cumulative incidence of adverse events
The number of adverse events reported throughout the study.
Time frame: Initial consent to final study visit (6 months)
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