StrokeMT-SRGNCT07467915
Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke
A study testing Conventional Rehabilitation, Mirror Therapy and Soft Robotic Glove in people with Stroke and Hemiplegia, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Hemiplegia, Upper Limb Motor Impairment
- What is being tested?
- Conventional Rehabilitation, Mirror Therapy and Soft Robotic Glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIraq
- Study dates
- 8 Apr 2026to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 understand and follow simple instructions, with a Six-Item Cognitive Impairment Test (6CIT) score of 9 or less.
- 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
Who cannot join
- 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 acuity worse than 6/12 on the Snellen chart, after correction where applicable, or inability to adequately see the reflected hand during mirror therapy
- Uncontrolled cardiovascular or other medical conditions that would prevent safe participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Hemiplegia, Upper Limb Motor Impairment
- Being tested
- Conventional Rehabilitation, Mirror Therapy, Soft Robotic Glove, Mirror Therapy plus Soft Robotic Glove
- Keywords
- Mirror Therapy, Soft Robotic Glove, Stroke Rehabilitation, Hand Function Recovery, Upper Limb Rehabilitation, Post-Stroke Hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RehabilitationOther
Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke
Mirror TherapyOther
A rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke.
Soft Robotic GloveDevice
A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke
Mirror Therapy plus Soft Robotic GloveCombination product
Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Participants receive conventional upper limb rehabilitation therapy according to standard clinical practice for stroke rehabilitation Receives: Other: Conventional Rehabilitation |
| Mirror Therapy | Experimental | Participants receive mirror therapy sessions designed to improve motor function of the affected upper limb following stroke. Receives: Other: Mirror Therapy |
| 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. Receives: Device: Soft Robotic Glove |
| 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. Receives: Combination Product: Mirror Therapy plus Soft Robotic Glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Wrist and Hand Fugl-Meyer Assessment (W/H FMA) Score
The Wrist/Hand Fugl-Meyer Assessment (W/H FMA) evaluates motor recovery of the affected wrist and hand following stroke. It consists of 12 items, including five wrist items and seven hand items. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 24. Higher scores indicate better wrist and hand motor function. Changes from baseline are assessed following the six-week intervention and at the three-month follow-up.
Measured: Baseline, 6 weeks (post-intervention), and 3 months after intervention completion.
Change From Baseline in Action Research Arm Test (ARAT) Score
The Action Research Arm Test (ARAT) evaluates upper-limb functional performance after stroke. It comprises 19 items across four subscales: grasp, grip, pinch, and gross movement. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 57. Higher scores indicate better upper-limb functional performance. Changes from baseline are assessed after the six-week intervention and at the three-month follow-up.
Measured: Baseline, 6 weeks (post-intervention), and 3 months after intervention completion.
Change From Baseline in Katz Index of Independence in Activities of Daily Living Score
The Katz Index of Independence in Activities of Daily Living (Katz ADL) assesses independence in six basic activities: bathing, dressing, toileting, transferring, continence, and feeding. Each activity is scored as 0 (dependent) or 1 (independent), producing a total score ranging from 0 to 6. Higher scores indicate greater independence. Changes from baseline are assessed after the six-week intervention and at the three-month follow-up.
Measured: Baseline, 6 weeks (post-intervention), and 3 months after intervention completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start8 Apr 2026
- Primary completion5 Oct 2026
- Study completion5 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hindi Jaryan, University of Baghdad
- Investigators
- Wafaa Hattab, PhD, Principal investigator, University of Baghdad, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467915
- Sponsor's protocol ID
- UOB-MT-SRG-RCT-2026
- Acronym
- MT-SRG
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 37371378Qian 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.
PubMed 40589984
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combining Mirror Therapy With Soft Robotic Glove on Hand Function Recovery in Post-Stroke Hemiplegic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07467915
- Acronym / sponsor ID
- MT-SRG / UOB-MT-SRG-RCT-2026
- Conditions
- Stroke, Hemiplegia, Upper Limb Motor Impairment
- Keywords
- Mirror Therapy, Soft Robotic Glove, Stroke Rehabilitation, Hand Function Recovery, Upper Limb Rehabilitation, Post-Stroke Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 5 Oct 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Other: Conventional RehabilitationParticipants receive conventional upper limb rehabilitation therapy according to standard clinical practice for stroke rehabilitation |
| Mirror Therapy | Experimental | Other: Mirror TherapyParticipants receive mirror therapy sessions designed to improve motor function of the affected upper limb following stroke. |
| Soft Robotic Glove Training | Experimental | Device: Soft Robotic GloveParticipants 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 | Experimental | Combination Product: Mirror Therapy plus Soft Robotic GloveParticipants receive a combined intervention consisting of mirror therapy and soft robotic glove training to enhance upper limb motor recovery after stroke. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 understand and follow simple instructions, with a Six-Item Cognitive Impairment Test (6CIT) score of 9 or less.
- Ability to sit independently for at least 30 minutes
- Medically stable and cleared to participate in rehabilitation interventions
Key exclusion criteria (6 listed)
- 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 acuity worse than 6/12 on the Snellen chart, after correction where applicable, or inability to adequately see the reflected hand during mirror therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional RehabilitationStandard rehabilitation therapy focused on improving upper limb function in individuals with stroke | Other | Conventional Rehabilitation |
| Mirror TherapyA rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke. | Other | Mirror Therapy |
| Soft Robotic GloveA wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke | Device | Soft Robotic Glove Training |
| Mirror Therapy plus Soft Robotic GloveParticipants receive a combined intervention consisting of mirror therapy and soft robotic glove training | Combination product | Mirror Therapy plus Soft Robotic Glove |
Primary outcome
Change From Baseline in Wrist and Hand Fugl-Meyer Assessment (W/H FMA) Score
Time frame: Baseline, 6 weeks (post-intervention), and 3 months after intervention completion.
The Wrist/Hand Fugl-Meyer Assessment (W/H FMA) evaluates motor recovery of the affected wrist and hand following stroke. It consists of 12 items, including five wrist items and seven hand items. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 24. Higher scores indicate better wrist and hand motor function. Changes from baseline are assessed following the six-week intervention and at the three-month follow-up.
Change From Baseline in Action Research Arm Test (ARAT) Score
Time frame: Baseline, 6 weeks (post-intervention), and 3 months after intervention completion.
The Action Research Arm Test (ARAT) evaluates upper-limb functional performance after stroke. It comprises 19 items across four subscales: grasp, grip, pinch, and gross movement. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 57. Higher scores indicate better upper-limb functional performance. Changes from baseline are assessed after the six-week intervention and at the three-month follow-up.
Change From Baseline in Katz Index of Independence in Activities of Daily Living Score
Time frame: Baseline, 6 weeks (post-intervention), and 3 months after intervention completion.
The Katz Index of Independence in Activities of Daily Living (Katz ADL) assesses independence in six basic activities: bathing, dressing, toileting, transferring, continence, and feeding. Each activity is scored as 0 (dependent) or 1 (independent), producing a total score ranging from 0 to 6. Higher scores indicate greater independence. Changes from baseline are assessed after the six-week intervention and at the three-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Results publication: PubMed 37371378Ko 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.
- Results publication: PubMed 40589984Qian 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa Hattab, PhD principal investigator
University of Baghdad, College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rehabilitation, Mirror Therapy and Soft Robotic Glove in people with Stroke and Hemiplegia, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Wrist and Hand Fugl-Meyer Assessment (W/H FMA) Score (time frame: Baseline, 6 weeks (post-intervention), and 3 months after intervention completion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.