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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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| Name | Class |
|---|---|
| Management Center Innsbruck (MCI), Austria | UNKNOWN |
| Yale School of Engineering Center for Engineering Innovation and Design | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Therapy Group | Active Comparator | Participants in this group with train using Mirror Therapy (MT), the current standard of care. |
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| Miraπ Group | Experimental | Participants in this group will train with the Miraπ device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miraπ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At admission and discharge up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rummana Aslam, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
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.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| 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 are patients admitted to the acute inpatient rehabilitation unit for rehabilitation of the hand and fingers who have one paralyzed hand without pronounced spasticity.
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| Mirror Therapy | Behavioral | Current standard of care using MT. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |