- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467915
Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke (MT-SRG)
Effect of Combining Mirror Therapy With Soft Robotic Glove on Hand Function Recovery in Post-Stroke Hemiplegic Patients: A Randomized Controlled Trial
Post-stroke hemiplegia frequently results in impaired upper limb function, which significantly affects independence and quality of life. Various rehabilitation approaches have been developed to improve motor recovery, including mirror therapy and robotic-assisted training. Mirror therapy uses visual feedback to stimulate neural plasticity and enhance motor recovery, while soft robotic gloves assist repetitive hand movements and facilitate functional training.
This randomized controlled trial aims to investigate the effect of combining mirror therapy with a soft robotic glove on hand function recovery in patients with post-stroke hemiplegia. Participants will be randomly assigned to different intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation.
The primary outcome will assess improvement in upper limb motor function using validated clinical assessment tools. Secondary outcomes will evaluate functional hand performance and activities of daily living. The findings of this study may contribute to improving rehabilitation strategies for stroke survivors and provide evidence for integrating innovative rehabilitation technologies into clinical practice.
Study Overview
Status
Conditions
Detailed Description
Stroke is one of the leading causes of long-term disability worldwide and commonly results in upper limb motor impairment. Recovery of hand function is essential for improving independence in activities of daily living. However, rehabilitation of the affected upper limb remains a major challenge in stroke management.
Mirror therapy is a rehabilitation technique that provides visual feedback by reflecting movements of the unaffected limb in a mirror, creating the illusion that the affected limb is moving normally. This approach is believed to promote cortical reorganization and enhance motor recovery. In recent years, robotic-assisted rehabilitation devices, including soft robotic gloves, have been developed to provide repetitive, task-specific training and facilitate motor relearning.
Soft robotic gloves are wearable assistive devices designed to support hand movements and enable repetitive practice of grasping and releasing tasks. These devices provide controlled assistance during rehabilitation exercises and may enhance the intensity and effectiveness of therapy.
This study is designed as a randomized controlled trial to evaluate the effectiveness of combining mirror therapy with soft robotic glove training in improving hand function among patients with post-stroke hemiplegia. Eligible participants will be randomly assigned to intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation.
The intervention program will be delivered over a structured rehabilitation period, and clinical assessments will be conducted at baseline and after completion of the intervention. Outcome measures will focus on upper limb motor recovery, hand function performance, and functional independence.
The results of this study are expected to provide evidence regarding the effectiveness of integrating mirror therapy with robotic-assisted rehabilitation approaches for improving upper limb recovery after stroke. This may support the development of more effective rehabilitation protocols for patients with post-stroke hemiplegia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed Hindi Jaryan, PhD Candidate
- Phone Number: +9647808046480
- Email: mhmdalwtyfy683@gmail.com
Study Locations
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Babylon
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Baghdad, Babylon, Iraq
- Recruiting
- Rehabilitation and Neurology Outpatient Unit
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Contact:
- Mohammed Hindi Jaryan, PhD Candidate
- Phone Number: +9647808046480
- Email: mhmdalwtyfy683@gmail.com
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Contact:
- Wafaa Jaryan, PhD
- Phone Number: +9647808046480
- Email: mhmdalwtyfy683@gmail.com
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Principal Investigator:
- Wafaa Hattab, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults aged 18-70 years with first-ever ischemic or hemorrhagic stroke confirmed by imaging (CT or MRI)
Moderate upper limb motor impairment (Fugl-Meyer Assessment Upper Extremity [FMA-UE] score 20-50)
Ability to follow simple instructions (Six-Item Cognitive Impairment Test, 6CIT)
Ability to sit independently for at least 30 minutes
Medically stable and cleared to participate in rehabilitation interventions
Willingness to provide informed consent and adhere to the study protocol
Exclusion Criteria:
Severe upper limb spasticity (Modified Ashworth Scale ≥ 3)
Cognitive or psychiatric disorders interfering with participation
Other neurological or musculoskeletal conditions affecting upper limb function (e.g., Parkinson's disease, multiple sclerosis, fractures)
Prior exposure to intensive Mirror Therapy or Soft Robotic Gloves
Visual impairment that cannot be corrected with glasses or contact lenses
Uncontrolled cardiovascular or other medical conditions that would prevent safe participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Rehabilitation
Participants receive conventional upper limb rehabilitation therapy according to standard clinical practice for stroke rehabilitation
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Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke
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Experimental: Mirror Therapy
Participants receive mirror therapy sessions designed to improve motor function of the affected upper limb following stroke.
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A rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke.
|
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Experimental: Soft Robotic Glove Training
Participants perform upper limb training using a soft robotic glove device to assist hand movement and improve motor recovery after stroke.
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A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke
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Experimental: Mirror Therapy plus Soft Robotic Glove
Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training to enhance upper limb motor recovery after stroke.
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Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)
Time Frame: Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up.
|
Assesses motor recovery of the affected upper limb following stroke, including voluntary movement, coordination, and reflex activity using a standardized stroke-specific motor scale.
Scores range from 0 to 66, with higher scores indicating better motor recovery and motor performance.
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Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up.
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Functional Use of Affected Limb (Functional Test of Upper Limb Hemiplegia - Hong Kong, FTHUE-HK)
Time Frame: Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up
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Evaluates functional use of the affected upper limb in individuals with hemiplegia through hierarchical task performance.
Scores range from Level 1 (no active movement) to Level 7 (advanced functional hand use), with higher levels indicating greater functional recovery.
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Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activities of Daily Living (Katz Index of Independence in ADL)
Time Frame: Baseline, 4 weeks, post-intervention, 3-month follow-up
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Measures the participant's ability to independently perform six basic self-care activities including bathing, dressing, toileting, transferring, continence, and feeding.
Scores range from 0 to 6, with higher scores indicating greater independence in activities of daily living.
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Baseline, 4 weeks, post-intervention, 3-month follow-up
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Upper Limb Spasticity (Modified Ashworth Scale, MAS)
Time Frame: Baseline, 4 weeks, post-intervention, 3-month follow-up
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Assesses muscle spasticity in the affected upper limb by grading resistance during passive soft-tissue stretching.
Scores range from 0 to 4, where higher scores indicate increased muscle tone and greater spasticity.
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Baseline, 4 weeks, post-intervention, 3-month follow-up
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Cognitive Screening (Six-Item Cognitive Impairment Test, 6CIT)
Time Frame: Baseline
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A brief screening tool used to assess cognitive status prior to study participation, including orientation, memory, and attention.
Scores range from 0 to 28, with higher scores indicating greater cognitive impairment.
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Baseline
|
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Visual Acuity (Snellen Chart)
Time Frame: Baseline
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Evaluates visual acuity to ensure participants can adequately perform mirror-based visual feedback during therapy.
Visual acuity is measured using the standard Snellen fraction (e.g., 6/6 to 6/60), where better vision corresponds to higher visual acuity.
|
Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wafaa Hattab, PhD, University of Baghdad, College of Nursing
Publications and helpful links
General Publications
- Ko MJ, Chuang YC, Ou-Yang LJ, Cheng YY, Tsai YL, Lee YC. The Application of Soft Robotic Gloves in Stroke Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2023 Jun 2;13(6):900. doi: 10.3390/brainsci13060900.
- Qian J, Liang C, Liu R, Yu J, Yang T, Bai D. Combination of robot-assisted glove and mirror therapy improves upper limb motor function in subacute stroke patients: a randomized controlled pilot study. Front Neurol. 2025 Jun 16;16:1602896. doi: 10.3389/fneur.2025.1602896. eCollection 2025.
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
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Paralysis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Hemiplegia
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Mirror Movement Therapy
Other Study ID Numbers
- UOB-MT-SRG-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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