- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460128
Digital Mirror Therapy in Stroke Rehabilitation
Digital Mirror Therapy in Poststroke Rehabilitation: Efficacy and Patient-reported Facilitators and Barriers to Adherence.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jack Jiaqi Zhang, PhD
- Phone Number: 27666696
- Email: jack-jiaqi.zhang@polyu.edu.hk
Study Contact Backup
- Name: Sofina Chan, MA
- Email: sofina.chan@polyu.edu.hk
Study Locations
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-
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Hong Kong, Hong Kong, 000000
- Recruiting
- Hong Kong Polytechnic University
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Contact:
- Jack Jiaqi Zhang
- Phone Number: 6696
- Email: jack-jiaqi.zhang@polyu.edu.hk
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Contact:
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Principal Investigator:
- Jack Jiaqi Zhang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: digital mirror therapy
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.
|
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.
|
|
Active Comparator: conventional 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.
They will participate three times per week in a maximal period of 21 days, for a total of 10 training sessions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fugl-Meyer Assessment Upper Extremity Scores
Time Frame: Baseline
|
Baseline
|
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Fugl-Meyer Assessment Upper Extremity Scores
Time Frame: After 3 weeks
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After 3 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jack Jiaqi Zhang, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20251026004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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