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Recruiting NCT07921108

Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial

Conditions: Stroke, Upper Extremity Paresis

Sex: All
Ages: 20 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Chang Gung Memorial Hospital

Location: Chang Gung Memorial Hospital Taoyuan

Summary

Background \& Objectives Upper extremity paresis represents one of the most prevalent and debilitating neurological sequelae following stroke, severely compromising survivors' independence in activities of daily living (ADLs). Among evidence-based interventions, action observation therapy (AOT) and mirror therapy (MT) have demonstrated clinical efficacy in augmenting upper limb functional recovery. Concurrently, telerehabilitation has emerged as a promising modality due to its clinical efficacy, accessibility, and cost-effectiveness. However, no prior investigation has directly compared telerehabilitation-delivered AOT alone versus combined AOT with mirror therapy (AOT-MT) in subacute stroke. This study aims to evaluate and compare the therapeutic effects of these two digital intervention paradigms on upper limb motor recovery and functional outcomes. Methods \& Technical Development A proprietary cross-platform mobile web application ("Neuro-Mirror Pro") was developed and clinically deployed. The platform incorporates standardized 12-movement upper extremity training modules, client-side WebRTC and CSS image rendering ensuring strict privacy compliance without cloud video storage, and adherence-optimizing features including breakpoint-resume tracking logic. Clinically, this study is a prospective, assessor-blinded, randomized controlled trial. Subacute stroke survivors with unilateral hemiparesis are recruited from an inpatient stroke rehabilitation ward. Eligible participants are stratified by baseline motor impairment severity (FMA-UE score) and the affected side (left vs. right hemiparesis), and subsequently randomized (1:1) to receive either app-based AOT alone or app-based combined AOT-MT. Both arms undergo a 4-week telerehabilitation intervention (36 minutes daily) in conjunction with conventional occupational therapy (1 hour daily on weekdays). Outcome Measures The primary outcome is upper extremity motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes include the modified Rankin Scale (mRS), Box and Block Test (BBT), ABILHAND questionnaire, short-form Quality of Movement Inventory (QMI), and app adherence/feasibility metrics. All outcomes are evaluated at baseline, 4 weeks (post-intervention), and 12 weeks (follow-up).

Eligibility Criteria

Inclusion Criteria: 1. Aged between 20 and 80 years. 2. First-ever unilateral hemispheric or brainstem stroke confirmed by neuroimaging (brain CT or MRI). 3. Subacute stroke stage, defined as stroke onset between 1 and 6 months prior to study enrollment. 4. Baseline Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 60, indicating moderate to mild-moderate upper limb motor impairment. 5. Preserved cognitive function sufficient to understand and follow verbal instructions, with the ability to operate a smartphone or touch-screen mobile device. Exclusion Criteria: 1. Diagnosis of global aphasia or severe receptive aphasia that precludes basic verbal communication or comprehension of study tasks. 2. Presence of severe hemispatial neglect. 3. Coexisting significant medical conditions or musculoskeletal disorders that substantially restrict the passive range of motion or active movement of the paretic upper limb. 4. Inability or refusal to use mobile touch-screen devices.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07921108). StuddyBuddy aggregates publicly available trial information.