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Recruiting NCT07460128

Digital Mirror Therapy in Stroke Rehabilitation

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: digital mirror therapy, conventional mirror therapy.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Digital Mirror Therapy in Poststroke Rehabilitation: Efficacy and Patient-reported Facilitators and Barriers to Adherence.

Overview

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.

Interventions

  • Behavioral digital mirror therapy
    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
  • Behavioral 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. Both groups will participate three times per week in a maximal period of 21 days, for a total of 10 training sessions.

Primary outcome measures

  • Fugl-Meyer Assessment Upper Extremity Scores [Time frame: Baseline]
  • Fugl-Meyer Assessment Upper Extremity Scores [Time frame: After 3 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 2 centers
  • Hong Kong Polytechnic University — Hong Kong
  • Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07460128 · HSEARS20251026004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗