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
1 other identifier
interventional
104
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Apr 2026
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedStudy Start
First participant enrolled
April 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 17, 2026
May 13, 2026
March 1, 2026
5 months
March 8, 2026
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Other Outcomes (4)
Activities of Daily Living (Katz Index of Independence in ADL)
Baseline, 4 weeks, post-intervention, 3-month follow-up
Upper Limb Spasticity (Modified Ashworth Scale, MAS)
Baseline, 4 weeks, post-intervention, 3-month follow-up
Cognitive Screening (Six-Item Cognitive Impairment Test, 6CIT)
Baseline
- +1 more other outcomes
Study Arms (4)
Conventional Rehabilitation
ACTIVE COMPARATORParticipants receive conventional upper limb rehabilitation therapy according to standard clinical practice for stroke rehabilitation
Mirror Therapy
EXPERIMENTALParticipants receive mirror therapy sessions designed to improve motor function of the affected upper limb following stroke.
Soft Robotic Glove Training
EXPERIMENTALParticipants perform upper limb training using a soft robotic glove device to assist hand movement and improve motor recovery after stroke.
Mirror Therapy plus Soft Robotic Glove
EXPERIMENTALParticipants receive a combined intervention consisting of mirror therapy and soft robotic glove training to enhance upper limb motor recovery after stroke.
Interventions
Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke
A rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke.
A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke
Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation and Neurology Outpatient Unit
Baghdad, Babylon, Iraq
Related Publications (2)
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: 37371378RESULTQian 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: 40589984RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wafaa Hattab, PhD
University of Baghdad, College of Nursing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate
Study Record Dates
First Submitted
March 8, 2026
First Posted
March 12, 2026
Study Start
April 8, 2026
Primary Completion (Estimated)
September 17, 2026
Study Completion (Estimated)
December 17, 2026
Last Updated
May 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.