An interventional study of App-based combined action observation and mirror therapy and App-based action observation therapy in Stroke and Upper Extremity Paresis, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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).
This study is a prospective, assessor-blinded, randomized controlled trial designed to evaluate and compare the therapeutic effects of a proprietary mobile web-based telerehabilitation platform delivering action observation therapy alone (AOT) versus combined action observation therapy with mirror therapy (AOT-MT) for upper extremity motor recovery in subacute stroke survivors.
Upper extremity hemiparesis is a prevalent and disabling complication following stroke, significantly limiting functional independence and participation in daily living. While conventional in-person rehabilitation yields positive outcomes, post-discharge adherence is often constrained by mobility limitations, geographic barriers, and clinical resource burdens. Telerehabilitation through mobile health (mHealth) applications offers a scalable and accessible alternative. However, clinical evidence directly comparing telerehabilitation-delivered AOT versus combined AOT-MT remains limited.
To address this gap, this trial utilizes "Neuro-Mirror Pro," a cross-platform mobile web telerehabilitation application. The software incorporates standardized 12-movement upper extremity rehabilitation modules, client-side WebRTC and CSS image transformation to achieve real-time mirror illusions without transferring raw patient video to cloud servers (ensuring data privacy), and breakpoint-resume tracking to optimize patient adherence.
Participants with subacute stroke (onset > 1 month) presenting with unilateral hemiparesis are recruited from an inpatient rehabilitation unit. Following baseline evaluation, participants are stratified by motor impairment severity (Fugl-Meyer Assessment for Upper Extremity, FMA-UE) and the side of hemiparesis (left vs. right), and then randomized (1:1) into either the AOT group or the combined AOT-MT group.
Both groups receive a 4-week telerehabilitation regimen consisting of 36 minutes of daily digital training, administered alongside conventional occupational therapy (1 hour daily on weekdays). Comprehensive outcome assessments are performed at baseline (pre-intervention), at 4 weeks (immediately post-intervention), and at 12 weeks post-baseline to assess retention and long-term functional recovery.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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Exclusion Criteria:
Participants receive a 4-week telerehabilitation intervention (36 minutes/day, 5 days/week) combining action observation therapy with client-side mirrored visual feedback via the "Neuro-Mirror Pro" mobile web platform, alongside conventional occupational therapy (1 hour/day on weekdays).
Behavioral: App-based combined action observation and mirror therapy
Participants receive a 4-week telerehabilitation intervention (36 minutes/day, 5 days/week) consisting of action observation therapy alone without mirror visual feedback via the "Neuro-Mirror Pro" mobile web platform, alongside conventional occupational therapy (1 hour/day on weekdays).
Behavioral: App-based action observation therapy
Participants receive a 4-week telerehabilitation regimen delivered via the "Neuro-Mirror Pro" mobile web application, consisting of 36 minutes per daily session, 5 days per week, in addition to regular conventional occupational therapy (1 hour daily on weekdays). The intervention integrates action observation therapy with client-side mirrored visual feedback. Participants observe standardized video demonstrations of 12 upper extremity functional movements while actively performing the movements. Real-time visual feedback is rendered locally using client-side WebRTC and CSS horizontal inversion, creating the visual illusion that the paretic arm is moving smoothly, thereby stimulating motor cortex reorganization without transmitting raw video data to external servers.
Participants receive a 4-week telerehabilitation regimen delivered via the "Neuro-Mirror Pro" mobile web application, consisting of 36 minutes per daily session, 5 days per week, in addition to regular conventional occupational therapy (1 hour daily on weekdays). The intervention consists of action observation therapy alone. Participants observe standardized video demonstrations of 12 upper extremity functional movements and actively perform the observed actions without mirrored visual feedback. Training adherence and completion are recorded client-side to ensure compliance and privacy without cloud video storage.
Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a widely recognized, stroke-specific performance-based impairment index designed to assess upper extremity motor recovery. It evaluates voluntary movement, reflex activity, grasping, and wrist/hand coordination across 33 items. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), yielding a total score ranging from 0 to 66, with higher scores indicating better upper limb motor function.
Time frame: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline
Change from Baseline in modified Rankin Scale (mRS) Score
The modified Rankin Scale (mRS) is a clinician-reported single-item measure of global disability and functional dependence following stroke. The scale ranges from 0 (no symptoms at all) to 6 (dead), with 0-2 indicating functional independence, 3 indicating moderate disability (requiring some help but able to walk without assistance), and 4-5 indicating severe disability and dependence. Lower scores reflect superior global functional independence.
Time frame: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline
Change from Baseline in Box and Block Test (BBT) Score
The Box and Block Test (BBT) evaluates gross manual dexterity by measuring the number of wooden blocks transferred one by one from one compartment of a divided box to the other within 60 seconds using the affected upper extremity. Higher scores indicate superior manual dexterity.
Time frame: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline
Change from Baseline in ABILHAND Questionnaire Score
The ABILHAND questionnaire is a patient-reported measure of manual ability during daily bimanual activities. Patients rate their perceived difficulty on 23 representative daily manual tasks as impossible (0), difficult (1), or easy (2). Ordinal scores are converted via Rasch analysis into a linear logit measure, where higher logit scores indicate greater ease and manual capability.
Time frame: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline
Change from Baseline in Short-form Quality of Movement Inventory (QMI) Score
The short-form Quality of Movement Inventory (QMI) assesses the qualitative performance and movement smoothness of the paretic upper limb during specific motor tasks. Higher scores denote improved quality of movement and less compensatory strategies.
Time frame: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline
Telerehabilitation System Feasibility, Usability, and Training Adherence
Feasibility, usability, and adherence are evaluated using a multi-metric approach: (1) training adherence rate, measured as the percentage of completed digital sessions relative to the prescribed 20 sessions (36 minutes daily, 5 days per week over 4 weeks) monitored via client-side breakpoint-resume tracking within the Neuro-Mirror Pro application; (2) dropout/retention rate; (3) platform usability assessed via the System Usability Scale (SUS, scored 0-100, where higher scores indicate superior usability); (4) user acceptance, perceived ease of use, and satisfaction assessed using the Technology Acceptance Model-2 (TAM-2, rated on a 5-point Likert scale) and the USE (Usefulness, Satisfaction, and Ease of Use) questionnaire (rated on a 7-point Likert scale); and (5) intervention safety, evaluated by tracking any study-related adverse events during the 4-week period.
Time frame: 4 weeks (immediately post-intervention)
Plan to share: No — Individual participant data will not be publicly shared to protect participant confidentiality and privacy in accordance with institutional review board and data governance regulations. Aggregated trial results and study outcomes will be fully published in peer-reviewed scientific journals.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jul 2028, 25 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 25 months is close to that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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