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The aim of the project is to compare the effects of unilateral hybrid therapy [unilateral robot-assisted therapy (RT)] + unilateral arm training (UAT)] and bilateral hybrid therapy [bilateral RT + bilateral arm training (BAT)] on motor function, daily function, mobility, life quality, and motor control strategy in stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral Hybrid Intervention Group | Experimental | Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session. |
|
| Bilateral Hybrid Intervention Group | Experimental | Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session. |
|
| Robot-Assisted Training Group | Experimental | Participants will receive 6 weeks of RT training using the BMT in each session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral Hybrid Intervention | Procedure | For the unilateral RT training, participants will practice with their affected arms following a unilateral training protocol of BMT for 45 minutes (Yang, et al., 2012). For the UAT training, participants will receive training of the affected UL in functional tasks with behavioral shaping for 45 minutes (Lin, Wu, et al., 2009). |
| Measure | Description | Time Frame |
|---|---|---|
| Change scores of Fugl-Meyer assessment(FMA) | baseline, 3 weeks, 6 weeks, 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test (WMFT) | baseline, 6 weeks | |
| Change scores of Box and block test (BBT) | baseline, 3 weeks, 6 weeks, 18 weeks | |
| Change scores of Action research arm test (ARAT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ching-Yi Wu, ScD | Contact | 886-3-2118800 | 5761 | cywu@mail.cgu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ching-Yi Wu, ScD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lo-Sheng Sanatorium and Hospital | Not yet recruiting | Kwei-shan | Toayuan County | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31421096 | Derived | Hung CS, Lin KC, Chang WY, Huang WC, Chang YJ, Chen CL, Grace Yao K, Lee YY. Unilateral vs Bilateral Hybrid Approaches for Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Dec;100(12):2225-2232. doi: 10.1016/j.apmr.2019.06.021. Epub 2019 Aug 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2022 | |
| Reset | Jul 14, 2022 | |
| Release | Jul 21, 2022 | |
| Reset | May 23, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2022 | Jul 14, 2022 | |||
| Jul 21, 2022 |
| 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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|
| Bilateral Hybrid Intervention | Procedure | For the bilateral RT training, patients will focus on training involving both arms using the BMT robot for 45 minutes. During the 45 minutes BAT training, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs. |
|
| Robot-Assisted Training | Procedure | The RT intervention will be matched in duration and intensity with the hybrid interventions. Participants in the RT group will practice on the BMT with bilateral protocols for 90 minutes. The tasks will be tailored according to the level |
|
| baseline, 3 weeks, 6 weeks |
| Change scores of Medical Research Council scale (MRC) | baseline, 3 weeks, 6 weeks |
| Change scores of Modified Ashworth scale (MAS) | baseline, 3 weeks, 6 weeks |
| Change scores of Myoton | baseline, 6 weeks |
| Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) | baseline, 6 weeks |
| Change scores of Functional independent measure (FIM) | baseline, 3 weeks, 6 weeks |
| Change scores of Stroke Impact Scale (SIS 3.0 version) | baseline, 3 weeks, 6 weeks, 18 weeks |
| Change scores of EuroQol Quality of Life Scale (EQ-5D) | baseline, 6 weeks |
| Change scores of Hand strength | baseline, 3 weeks, 6 weeks |
| Change scores of Motor activity log (MAL) | baseline, 6 weeks, 18 weeks |
| Change scores of ABILHAND Questionnaire | baseline, 6 weeks, 18 weeks |
| Change scores of 10-meter walking test | baseline, 6 weeks |
| Change scores of Nottingham Extended ADL Questionnaire (NEADL) | baseline, 6 weeks, 18 weeks |
| Change scores of Adelaide Activities Profile (AAP) | baseline, 6 weeks |
| Change scores of Accelerometer | baseline, 6 weeks |
| Change scores of kinematic analysis | baseline, 6 weeks |
| Change scores of Adverse effects | baseline, 3 weeks, 6 weeks |
| Change scores of Algometer | baseline, 6 weeks |
| Change scores of Revised Nottingham Sensory Assessment (rNSA) | baseline, 6 weeks |
| Chang Gung Memorial Hospital | Not yet recruiting | Kwei-Shan, Tao-Yuan | 333 | Taiwan |
|
| Taipei Hospital, Ministry of Health and Welfare | Recruiting | New Taipei City | Taiwan |
| May 23, 2023 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |