Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After 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: Conventional Rehabilitation, Mirror Therapy, Soft Robotic Glove, Mirror Therapy plus Soft Robotic Glove.
- Who it may be relevant to
- Registry conditions: Stroke, Hemiplegia, Upper Limb Motor Impairment. Basic parameters: 18 years — 70 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
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Combining Mirror Therapy With Soft Robotic Glove on Hand Function Recovery in Post-Stroke Hemiplegic Patients: A Randomized Controlled Trial
Overview
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.
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.
Interventions
- Other Conventional Rehabilitation
Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke - Other Mirror Therapy
A rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke. - Device Soft Robotic Glove
A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke - Combination product Mirror Therapy plus Soft Robotic Glove
Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training
Primary outcome measures
- 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.]
- 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]
Eligibility criteria
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
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
- Open label
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- Rehabilitation and Neurology Outpatient Unit — Baghdad
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. PMID 37371378
- 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. PMID 40589984
Identifiers
NCT: NCT07467915 · UOB-MT-SRG-RCT-2026