StrokeNCT06777654
Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation
A study testing Robotic therapy (RT) and Mirror therapy (MT) in people with Stroke, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
The goal of this clinical trial is to compare the effects of three groups: (1) unilateral robotic therapy with computerized visual feedback plus unilateral innovative mirror therapy, (2) bilateral robotic therapy with computerized visual feedback plus bilateral innovative mirror therapy, and (3) dose-matched… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic therapy (RT) and Mirror therapy (MT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesTaiwan
- Study dates
- 31 Mar 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a first ever-stroke≧3 months and less than 2 years, (2) age range between 30 to 80 years, (3) baseline Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) between 18 to 56, (4) no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints), (5) able to follow examiners' commands and study instructions (Montreal Cognitive Assessment score≧22), and (6) no fracture of upper extremities within the past 3 months, and (7) no participation in any other experimental rehabilitation or drug studies during study period of this project.
Who cannot join
- acute inflammation and pain, (2) receiving botulinum toxin injections within the past 3 months, and (3) concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation in this research.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites
Wan Fang Hospital, Taipei Medical University
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
About this study
Official title: Unilateral and Bilateral Approaches to Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation
The goal of this clinical trial is to compare the effects of three groups: (1) unilateral robotic therapy with computerized visual feedback plus unilateral innovative mirror therapy, (2) bilateral robotic therapy with computerized visual feedback plus bilateral innovative mirror therapy, and (3) dose-matched conventional rehabilitation as the control. The investigators will also study the factors predictive of treatment success, identify key predictors of clinical improvement, and distinguish patient profiles most likely to benefit from each regimen. The findings of this clinical trial are expected to advance knowledge about the synergistic effects of unilateral and bilateral hybrid programs. The predictive study of treatment outcomes will inform patient selection in precision rehabilitation toward personalized stroke management.
- Conditions
- Stroke
- Being tested
- Robotic therapy (RT), Mirror therapy (MT), Dose-matched control intervention
- Keywords
- Robotic Rehabilitation, Mirror Therapy, Stroke Rehabilitation, Computerized Rehabilitation, Randomized Controlled Trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic therapy (RT)Other
The Bi-Manu-Track (BMT) robot will be provided as the robotic practice. The BMT can be switched from the bilateral practice modules involving bilateral upper limbs to the unilateral module involving the affected upper limb. According to the group assignment, participants will practice the unilateral or bilateral module of BMT training.
Mirror therapy (MT)Other
The innovative mirror therapy (MT) program will be conducted with computerized mirror visual feedback and the conventional mirror box therapy. The unilateral MT group will practice on the unilateral module, while the bilateral MT group will practice based on the bilateral module. In the unilateral module, the affected hand will be static on the knee. In contrast, during bilateral MT, participants will be asked to do the same movements using the unaffected and affected arms as symmetrically as possible.
Dose-matched control interventionOther
Participants in the control group will receive therapist-mediated rehabilitation per session.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral RT plus unilateral innovative MT | Experimental | Unilateral robotic therapy (RT) with computerized visual feedback plus unilateral innovative mirror therapy (MT) Receives: Other: Robotic therapy (RT); Other: Mirror therapy (MT) |
| Bilateral RT plus bilateral innovative MT | Experimental | Bilateral robotic therapy (RT) with computerized visual feedback plus bilateral innovative mirror therapy (MT) Receives: Other: Robotic therapy (RT); Other: Mirror therapy (MT) |
| Dose-matched conventional rehabilitation | Active comparator | Dose-matched conventional rehabilitation as the control Receives: Other: Dose-matched control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)
Measured: Baseline, 6 weeks, and 18 weeks
Secondary outcomes (7)
Grip and pinch strength
Measured: Baseline, 6 weeks, and 18 weeks
Box and Block Test (BBT)
Measured: Baseline, 6 weeks, and 18 weeks
Revised Nottingham Sensory Assessment (rNSA)
Measured: Baseline, 6 weeks, and 18 weeks
Motor Activity Log (MAL)
Measured: Baseline, 6 weeks, and 18 weeks
ABILHAND Questionnaire
Measured: Baseline, 6 weeks, and 18 weeks
Functional Ambulation Category (FAC)
Measured: Baseline, 6 weeks, and 18 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
Measured: Baseline, 6 weeks, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start31 Mar 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777654
- Sponsor's protocol ID
- 202410139RIND
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral and Bilateral Approaches to Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06777654
- Acronym / sponsor ID
- 202410139RIND
- Conditions
- Stroke
- Keywords
- Robotic Rehabilitation, Mirror Therapy, Stroke Rehabilitation, Computerized Rehabilitation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 16 Jan 2025 (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.
The goal of this clinical trial is to compare the effects of three groups: (1) unilateral robotic therapy with computerized visual feedback plus unilateral innovative mirror therapy, (2) bilateral robotic therapy with computerized visual feedback plus bilateral innovative mirror therapy, and (3) dose-matched conventional rehabilitation as the control. The investigators will also study the factors predictive of treatment success, identify key predictors of clinical improvement, and distinguish patient profiles most likely to benefit from each regimen. The findings of this clinical trial are expected to advance knowledge about the synergistic effects of unilateral and bilateral hybrid programs. The predictive study of treatment outcomes will inform patient selection in precision rehabilitation toward personalized stroke management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral RT plus unilateral innovative MT | Experimental | Other: Robotic therapy (RT), Other: Mirror therapy (MT)Unilateral robotic therapy (RT) with computerized visual feedback plus unilateral innovative mirror therapy (MT) |
| Bilateral RT plus bilateral innovative MT | Experimental | Other: Robotic therapy (RT), Other: Mirror therapy (MT)Bilateral robotic therapy (RT) with computerized visual feedback plus bilateral innovative mirror therapy (MT) |
| Dose-matched conventional rehabilitation | Active comparator | Other: Dose-matched control interventionDose-matched conventional rehabilitation as the control |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a first ever-stroke≧3 months and less than 2 years, (2) age range between 30 to 80 years, (3) baseline Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) between 18 to 56, (4) no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints), (5) able to follow examiners' commands and study instructions (Montreal Cognitive Assessment score≧22), and (6) no fracture of upper extremities within the past 3 months, and (7) no participation in any other experimental rehabilitation or drug studies during study period of this project.
Key exclusion criteria (1 listed)
- acute inflammation and pain, (2) receiving botulinum toxin injections within the past 3 months, and (3) concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation in this research.
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 |
|---|---|---|
| Robotic therapy (RT)The Bi-Manu-Track (BMT) robot will be provided as the robotic practice. The BMT can be switched from the bilateral practice modules involving bilateral upper limbs to the unilateral module involving the affected upper limb. According to the group assignment, participants will practice the unilateral or bilateral module of BMT training. | Other | Bilateral RT plus bilateral innovative MT, Unilateral RT plus unilateral innovative MT |
| Mirror therapy (MT)The innovative mirror therapy (MT) program will be conducted with computerized mirror visual feedback and the conventional mirror box therapy. The unilateral MT group will practice on the unilateral module, while the bilateral MT group will practice based on the bilateral module. In the unilateral module, the affected hand will be static on the knee. In contrast, during bilateral MT, participants will be asked to do the same movements using the unaffected and affected arms as symmetrically as possible. | Other | Bilateral RT plus bilateral innovative MT, Unilateral RT plus unilateral innovative MT |
| Dose-matched control interventionParticipants in the control group will receive therapist-mediated rehabilitation per session. | Other | Dose-matched conventional rehabilitation |
Primary outcome
Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)
Time frame: Baseline, 6 weeks, and 18 weeks
7 secondary outcomes
Grip and pinch strength
Time frame: Baseline, 6 weeks, and 18 weeks
Box and Block Test (BBT)
Time frame: Baseline, 6 weeks, and 18 weeks
Revised Nottingham Sensory Assessment (rNSA)
Time frame: Baseline, 6 weeks, and 18 weeks
Motor Activity Log (MAL)
Time frame: Baseline, 6 weeks, and 18 weeks
ABILHAND Questionnaire
Time frame: Baseline, 6 weeks, and 18 weeks
Functional Ambulation Category (FAC)
Time frame: Baseline, 6 weeks, and 18 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: Baseline, 6 weeks, and 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic therapy (RT) and Mirror therapy (MT) in people with Stroke, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) (time frame: Baseline, 6 weeks, and 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.