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The researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. The aim of this study is to determine the validity and feasibility of enhanced reality in hemiparetic arm in the stroke patients with central nervous system injury.
Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after initiation of the intervention; 30 days after termination of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced reality | Experimental | Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes. ER therapy is provided 2 times a day for 10 minutes for 2 weeks (10 days of treatment week), except for time of installation, calibration, and 3 minute breaks. |
|
| No Enhanced reality | Active Comparator | Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced reality | Device | This prototype is developed by investigators for the first time so that it have no trademark or manufacturer name yet. The patient sits facing the horizontal desk with the ER therapy device, and then raises the wrist joint to the fixed base. The hand, wrist, and distal forearm to be treated are positioned below the ER medical camera so that the wrist is visible on the screen. Fix the wrist and wrist joint using Velcro. When treating the distal forearm, detach the wrist fixing Velcro. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Jebsen Taylor test | Jebsen-Taylor Hand Function Test | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Arm motor Fugl-Mayer scale | Arm motor Fugl-Mayer scale; wrist & hand/proximal arm | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Ashworth scale | Ashworth scale; wrist/ elbow | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Change of 9-hole pegboard |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Ho Hwang | Contact | +82-52-250-7210 | chhwang1220ciba@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Ho Hwang, M.D., Ph.D. | Ulsan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Recruiting | Ulsan | 682-714 | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| No Enhanced reality | Other | Identical rehabilitation without enhanced reality |
|
9-hole pegboard
| 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Change of Stroke impact scale | Stroke impact scale, hand function | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Change of Grasp force in Newtons | Grasp force in Newtons | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Change of Active range of motion of wrist joint | range of motion of the wrist joint | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Change of Korean-modified Barthel index | Korean version-Modified Barthel Index | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| Change of motor evoked potential of abdutor pollicis brevis | Motor Evoked Potential | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |