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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Rehabilitation | Active Comparator | Participants receive conventional upper limb rehabilitation therapy according to standard clinical practice for stroke rehabilitation |
|
| Mirror Therapy | Experimental | Participants receive mirror therapy sessions designed to improve motor function of the affected upper limb following stroke. |
|
| Soft Robotic Glove Training | Experimental | 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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| Mirror Therapy plus Soft Robotic Glove | Experimental | Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training to enhance upper limb motor recovery after stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Rehabilitation | Other | Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE) | 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. | 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) | 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. | Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Activities of Daily Living (Katz Index of Independence in ADL) | 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. | Baseline, 4 weeks, post-intervention, 3-month follow-up |
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Hindi Jaryan, PhD Candidate | Contact | +9647808046480 | mhmdalwtyfy683@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wafaa Hattab, PhD | University of Baghdad, College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation and Neurology Outpatient Unit | Recruiting | Baghdad | Babylon | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37371378 | Result | 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. | |
| 40589984 | Result | 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. |
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Individual participant data (IPD) will not be shared publicly in order to protect the privacy and confidentiality of study participants. Only summarized and aggregated results will be reported in scientific publications and research reports.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000088762 | Mirror Movement Therapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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Participants will be randomly assigned to one of four parallel groups: conventional rehabilitation, mirror therapy, soft robotic glove training, or a combination of mirror therapy and soft robotic glove intervention for upper limb rehabilitation after stroke.
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| Mirror Therapy | Other | 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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| Soft Robotic Glove | Device | A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke |
|
| Mirror Therapy plus Soft Robotic Glove | Combination Product | Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training |
|
| Upper Limb Spasticity (Modified Ashworth Scale, MAS) | 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. | Baseline, 4 weeks, post-intervention, 3-month follow-up |
| Cognitive Screening (Six-Item Cognitive Impairment Test, 6CIT) | 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. | Baseline |
| Visual Acuity (Snellen Chart) | 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |