NCT07460128

Brief Summary

Background: While conventional mirror therapy is a Level A recommended rehabilitation for poststroke upper extremity recovery, digital mirror therapy-enabled by augmented reality and computer vision-offers a promising alternative with potential for greater engagement and enriched sensory feedback. However, systematic comparisons of their clinical and physiological benefits, alongside an understanding of patient experiences with digital therapy, are lacking. Objectives: This randomized controlled trial will compare the efficacy of digital versus conventional mirror therapy for upper extremity rehabilitation in people after chronic stroke. The evaluation will focus on three areas: 1) clinical outcomes in motor function and community integration; 2) musculoskeletal physiological mechanisms, assessed through upper extremity muscle co-activation patterns; and 3) patient-reported barriers and facilitators to adherence with the digital technology. Methods: A parallel-group, assessor-blinded randomized controlled trial will be conducted. Participants with chronic stroke will be randomized to receive either digital or conventional mirror therapy three times per week for a total of 10 sessions over 21 days. The quantitative outcomes will be upper extremity function (using clinical scales), community integration (using a dedicated scale), and muscle activation/co-activation patterns during functional tasks (measured via surface electromyography \[EMG\]). The qualitative outcome will be patient-experienced barriers and facilitators, which will be explored through focus groups. Expected Results: This project aims to determine whether digital mirror therapy yields superior clinical outcomes compared to the conventional protocol. We hypothesize that greater improvement in upper extremity motor function will be associated with increased voluntary activation of task-relevant muscles and a reduction in abnormal co-contraction patterns. Furthermore, the qualitative findings will provide insights into the practical facilitators and barriers to patient adherence to digital technological rehabilitation, which will guide its future development and real-world clinical implementation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
32mo left

Started Mar 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2028

Study Start

First participant enrolled

March 2, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

StrokeObservational imitation trainingMirror therapyUpper extremity

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment Upper Extremity Scores

    Baseline

  • Fugl-Meyer Assessment Upper Extremity Scores

    After 3 weeks

Study Arms (2)

digital mirror therapy

EXPERIMENTAL

For the digital mirror therapy, we will use a self-developed digital visual feedback system to deliver the intervention. We will design 6-8 upper limb functional training tasks for each patient, according to the level of upper extremity functioning. Patients will complete these tasks under the guidance of the investigator during each training session. The digital mirror therapy will be delivered through an augmented reality system with virtual objects and enhanced visual feedback onto the patient's view of their affected upper extremity. Each task will be repeated 20 times per session, with the total duration of each session being approximately 45-60 minutes. Participants will participate three times per week in a maximal period of 21 days, for a total of 10 training sessions.

Behavioral: digital mirror therapy

conventional mirror therapy

ACTIVE COMPARATOR

The conventional mirror therapy group will receive the identical dose and structure of training but using a physical mirror. The therapy will be performed using a conventional mirror and common physical objects for task-oriented practice. They will participate three times per week in a maximal period of 21 days, for a total of 10 training sessions.

Behavioral: conventional mirror therapy

Interventions

In the digital mirror therapy, we will use a self-developed digital visual feedback system to deliver the intervention. We will design 6-8 upper limb functional training tasks for each patient, according to the level of upper extremity functioning. Patients will complete these tasks under the guidance of the investigator during each training session. The digital mirror therapy will be delivered through an augmented reality system with virtual objects and enhanced visual feedback onto the patient's view of their affected upper extremity. Each task will be repeated 20 times per session, with the total duration of each session being approximately 45-60 minutes.

digital mirror therapy

The conventional mirror therapy group will receive the identical dose and structure of training but using a physical mirror. The therapy will be performed using a conventional mirror and common physical objects for task-oriented practice. Both groups will participate three times per week in a maximal period of 21 days, for a total of 10 training sessions.

conventional mirror therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of ischemic or hemorrhagic stroke more than 6 months;
  • age between 18 and 80 years;
  • upper limb function rated at levels 2-6 according to the Functional Test for Hemiplegic Extremity Hong Kong Version

You may not qualify if:

  • any concomitant neurological disease other than stroke;
  • signs of cognitive impairment, defined as a score below 6 out of 10 on the Abbreviated Mental Test - Hong Kong Version ;
  • or severe spasticity in the hemiparetic upper extremity muscles, with a Modified Ashworth Scale score greater than 2;
  • unable to express thoughts effectively through verbal speech or written language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hong Kong Polytechnic University

Hong Kong, 000000, Hong Kong

RECRUITING

Hong Kong Polytechnic University

Hong Kong, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jack Jiaqi Zhang

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Jiaqi Zhang, PhD

CONTACT

Sofina Chan, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations