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StrokeNCT07921108

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

A study testing App-based combined action observation and mirror therapy and App-based action observation therapy in people with Stroke and Upper Extremity Paresis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Stroke, Upper Extremity Paresis
What is being tested?
App-based combined action observation and mirror therapy and App-based action observation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
30 Jun 2026to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 20 and 80 years.
  • First-ever unilateral hemispheric or brainstem stroke confirmed by neuroimaging (brain CT or MRI).
  • Subacute stroke stage, defined as stroke onset between 1 and 6 months prior to study enrollment.
  • Baseline Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 60, indicating moderate to mild-moderate upper limb motor impairment.
  • Preserved cognitive function sufficient to understand and follow verbal instructions, with the ability to operate a smartphone or touch-screen mobile device.

Who cannot join

  • Diagnosis of global aphasia or severe receptive aphasia that precludes basic verbal communication or comprehension of study tasks.
  • Presence of severe hemispatial neglect.
  • Coexisting significant medical conditions or musculoskeletal disorders that substantially restrict the passive range of motion or active movement of the paretic upper limb.
  • Inability or refusal to use mobile touch-screen devices.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chia-Ying Chung, M.D. contact

Taiwan1 site, 1 recruiting
  • Chang Gung Memorial Hospital

    Taoyuan

    Chih-Chi Chen, M.D., 001-886-3-3281200 ext. 3846, claudia5477@gmail.com

    Chia-Ying Chung, M.D., 001-886-3-3281200 ext. 3846

    Recruiting

Other trials in Taiwan

About this study

Official title: Effects of Mobile Device Delivered Action Observation Therapy and Mirror-based Action Observation Therapy for Post- Stroke Telerehabilitation: A Randomized Control Trial

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.

Read more

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).

Read the detailed description

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.

Being tested
App-based combined action observation and mirror therapy, App-based action observation therapy
Keywords
Stroke, Upper extremity rehabilitation, Telerehabilitation, Action observation therapy (AOT), Mirror therapy (MT)
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App-based combined action observation and mirror therapyBehavioural

    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.

  • App-based action observation therapyBehavioural

    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.

Study groups in NCT07921108
Study groupRoleWhat they receive
AOT-MT GroupExperimentalParticipants 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).
Receives: Behavioral: App-based combined action observation and mirror therapy
AOT GroupActive comparatorParticipants 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).
Receives: Behavioral: App-based action observation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline

Secondary outcomes (5)
  1. 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.

    Measured: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline

  2. 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.

    Measured: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline

  3. 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.

    Measured: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline

  4. 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.

    Measured: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline

  5. 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.

    Measured: 4 weeks (immediately post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start30 Jun 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07921108
Sponsor's protocol ID
202302120B0C1002
Other IDs
NMRPG3Q6112
Status last verified
Nov 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing App-based combined action observation and mirror therapy and App-based action observation therapy in people with Stroke and Upper Extremity Paresis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chih-Chi Chen, M.D. (001-886-3-3281200 ext. 3846, claudia5477@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score (time frame: Baseline, 4 weeks (immediately post-intervention), and 12 weeks post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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