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The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.
Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.
There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand Robotic Training | Experimental | Hand Robotic Training |
|
| Hand and Arm Robotic Training | Experimental | Hand and Arm Robotic Training |
|
| Conventional therapy | Active Comparator | Conventional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Robotic Training | Device | Training for 20 sessions for one hour, 3-5 times per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment | Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. | Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months |
| Action Research Arm Test | Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. | Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond KY Tong, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
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| Label | URL |
|---|---|
| The Hong Kong Polytechnic University | View source |
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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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| Hand and Arm Robotic Training | Device | Training for 20 sessions for one hour, 3-5 times per week. |
|
| Conventional therapy | Other | Training for 20 sessions for one hour, 3-5 times per week. |
|
| Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months |
| modified Ashworth Scale | Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. | Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |