Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Unilateral Hybrid Intervention
* Procedure: Bilateral Hybrid Intervention
* Procedure: Robot-Assisted Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥3 months onset from a first-ever unilateral stroke; minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits); an initial FMA-UE score of 10 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment; no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers); able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 22); without upper extremity fracture within 3 months; no participation in any rehabilitation experiments or drug studies during the study period; and (8) willing to provide written informed consent. Exclusion Criteria: acute inflammatory disease; major health problems or poor physical condition that might limit participation; and (3) attend any other study in recent 3 months.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral Hybrid Intervention Group<br>Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session. | Procedure: Unilateral Hybrid Intervention<br>* 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).<br>|
| Experimental: Bilateral Hybrid Intervention Group<br>Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session. | Procedure: Bilateral Hybrid Intervention<br>* 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.<br>|
| Experimental: Robot-Assisted Training Group<br>Participants will receive 6 weeks of RT training using the BMT in each session. | Procedure: Robot-Assisted Training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change scores of Fugl-Meyer assessment(FMA) |  | baseline, 3 weeks, 6 weeks, 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke rehabilitation, robot-assisted therapy, hybrid therapy