StrokeNCT06296628
Rehabilitation Device for Hand Mirror Therapy
A study testing Miraπ and Mirror Therapy in people with Stroke, run by Yale University at 1 site in United States.
Trial summary
This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Miraπ and Mirror Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 1 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants currently accepted and cleared for rehabilitation in the inpatient rehabilitation unit by the rehabilitation medical director.
- Participants with paralysis or motor function problems of only one hand.
- Participants spasticity of the affected hand ( as assessed by by the occupational therapist)
- Participants need mirror therapy because of their health condition.
- Participants are able to memorize easy tasks, and able to follow instructions e.g., moving the healthy fingers.
Who cannot join
- Participants who are not cleared physically or medically to participate in standard acute inpatient rehabilitation therapies by the rehabilitation medical director
- Participants who are not able to memorize easy tasks, e.g., moving the healthy fingers.
- Participants with spasticity of the affected hand ( as assed by the occupational therapist)
- Vulnerable populations
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital
Bridgeport, Connecticut, 06610
About this study
Official title: Comparative Study on Mirror Therapy With a Rehabilitation Device for Training of Affected Fingers
This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week.
Read the detailed description
The investigators hypothesize that the physical MT with Miraπ with physical movement of the affected hand will be generating a better patient outcome than conventional MT. Until now MT is performed in front of a mirror with the help of an occupational therapist, which can prove to be difficult. The affected hand of the patient is not moved during training. For the reasons mentioned, the mirror therapy device MIRAπ was developed. With MIRAπ, no mirror is needed and the affected hand is also physically moved by the device. Therefore, this clinical trial will focus on evaluating the device to see if it works better than conventional MT and therefore creates greater benefits to the patients.
- Conditions
- Stroke
- Being tested
- Miraπ, Mirror Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraπDevice
This device has tiny sensors that measure the movement of the healthy fingers and tiny motors that move the affected fingers of the patient.
The device is connected to a specially designed finger mechanism that moves the affected fingers of the patient. This opening mechanism is designed in a way that it prevents the fingers from being forced into any hurting position. If the patient moves the healthy fingers during training, also the fingers of the affected hand are moved by the device at the same time. This creates the effect of mirror therapy for the brain as the patient can see both hands moving.
Mirror TherapyBehavioural
Current standard of care using MT.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy Group | Active comparator | Participants in this group with train using Mirror Therapy (MT), the current standard of care. Receives: Behavioral: Mirror Therapy |
| Miraπ Group | Experimental | Participants in this group will train with the Miraπ device. Receives: Device: Miraπ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Jebsen-Taylor Hand Function Test score
Percentage score, which determines how well a participant can do motor tasks for range of motion, strength, and tasks of activities of daily life. Participants have up to 120 seconds to complete tasks. Lower scores indicate less impairment.
Measured: At admission and discharge up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start4 Apr 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
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 Yale UniversityThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are patients admitted to the acute inpatient rehabilitation unit for rehabilitation of the hand and fingers who have one paralyzed hand without pronounced spasticity.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Management Center Innsbruck (MCI), Austria, Yale School of Engineering Center for Engineering Innovation and Design
- Responsible party
- Sponsor
- Investigators
- Rummana Aslam, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296628
- Sponsor's protocol ID
- 2000037049
- Other IDs
- 000
- Status last verified
- Jun 2025
- First submitted
- 28 Feb 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The plan is to submit abstract of the study to Association of Academic Physiatrists and to publish in peer reviewed engineering and rehabilitation journals. The PI holds the primary responsibility for publishing the study results.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Mirror Therapy With a Rehabilitation Device for Training of Affected Fingers
- ClinicalTrials.gov ID
- NCT06296628
- Acronym / sponsor ID
- 2000037049
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Management Center Innsbruck (MCI), Austria, Yale School of Engineering Center for Engineering Innovation and Design
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Mar 2024 (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.
This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week.
Detailed description
The investigators hypothesize that the physical MT with Miraπ with physical movement of the affected hand will be generating a better patient outcome than conventional MT. Until now MT is performed in front of a mirror with the help of an occupational therapist, which can prove to be difficult. The affected hand of the patient is not moved during training. For the reasons mentioned, the mirror therapy device MIRAπ was developed. With MIRAπ, no mirror is needed and the affected hand is also physically moved by the device. Therefore, this clinical trial will focus on evaluating the device to see if it works better than conventional MT and therefore creates greater benefits to the patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are patients admitted to the acute inpatient rehabilitation unit for rehabilitation of the hand and fingers who have one paralyzed hand without pronounced spasticity.
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy Group | Active comparator | Behavioral: Mirror TherapyParticipants in this group with train using Mirror Therapy (MT), the current standard of care. |
| Miraπ Group | Experimental | Device: MiraπParticipants in this group will train with the Miraπ device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants currently accepted and cleared for rehabilitation in the inpatient rehabilitation unit by the rehabilitation medical director.
- Participants with paralysis or motor function problems of only one hand.
- Participants spasticity of the affected hand ( as assessed by by the occupational therapist)
- Participants need mirror therapy because of their health condition.
- Participants are able to memorize easy tasks, and able to follow instructions e.g., moving the healthy fingers.
Key exclusion criteria (4 listed)
- Participants who are not cleared physically or medically to participate in standard acute inpatient rehabilitation therapies by the rehabilitation medical director
- Participants who are not able to memorize easy tasks, e.g., moving the healthy fingers.
- Participants with spasticity of the affected hand ( as assed by the occupational therapist)
- Vulnerable populations
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 |
|---|---|---|
| MiraπThis device has tiny sensors that measure the movement of the healthy fingers and tiny motors that move the affected fingers of the patient. The device is connected to a specially designed finger mechanism that moves the affected fingers of the patient. This opening mechanism is designed in a way that it prevents the fingers from being forced into any hurting position. If the patient moves the healthy fingers during training, also the fingers of the affected hand are moved by the device at the same time. This creates the effect of mirror therapy for the brain as the patient can see both hands moving. | Device | Miraπ Group |
| Mirror TherapyCurrent standard of care using MT. | Behavioural | Conventional Therapy Group |
Primary outcome
Change in Jebsen-Taylor Hand Function Test score
Time frame: At admission and discharge up to 4 weeks
Percentage score, which determines how well a participant can do motor tasks for range of motion, strength, and tasks of activities of daily life. Participants have up to 120 seconds to complete tasks. Lower scores indicate less impairment.
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 5 Jun 2025.
- Individual participant dataSharing planned: No. The plan is to submit abstract of the study to Association of Academic Physiatrists and to publish in peer reviewed engineering and rehabilitation journals. The PI holds the primary responsibility for publishing the study results.
Related trials for Stroke
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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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.
Rummana Aslam, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miraπ and Mirror Therapy in people with Stroke, run by Yale University at 1 site in United States.
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 5 inclusion and 4 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 5 Jun 2025. 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 United States. 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 in Jebsen-Taylor Hand Function Test score (time frame: At admission and discharge up to 4 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 5 Jun 2025.