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The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.
This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Occupational Therapy (OT) | Active Comparator | Standard of care occupational therapy for stroke recovery |
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| OT + Device-assisted therapy | Experimental | Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. The m2 BAT will enable repeated movement of the affected body part without the help of a therapist, providing the opportunity to maintain range-of motion in the affected limb to limit spasticity, contracture and the ensuing deformity, a major goal of rehabilitation therapy and produces movement in the affected limb from activating the patient's own brain, rather than from being acted on by an external powered source such as a robot. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Occupational Therapy (OT) | Other | Standard of care occupational therapy for stroke recovery |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance tasks of the Fugl-Meyer Scale (FMS) | This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66. | 12 Weeks |
| Upper extremity functional ability measured with Modified Rankin Scale | 12 Weeks | |
| Stroke-related quality of life measured with the Stroke Impact Scale | 12 Weeks | |
| Spasticity measured using the Modified Ashworth Scale | 12 Weeks | |
| Range of motion will be measured using video | Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms. | 12 Weeks |
| Upper extremity functional ability measured using the Wolf Motor Function Test | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Tafurt, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
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| m2 BAT | Device | Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. |
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