Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training

Study Overview
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Brief Summary
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The purpose of this study is to compare the training effects of robot-assisted therapy focus on proximal part, distal part, or total segment of upper extremity, respectively.

Official Title
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Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Device: proximal robot-assisted therapy
* Device: distal robot-assisted therapy
* Behavioral: individualized intensive therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral stroke that verified by CT scan Time since stroke more than 6 months moderate and mild upper limb motor impairment identified from the UE subtest of FMA range from 10 to 50 Mini-Mental State Examination (MMSE) more than 24 points is needed to follow commands Exclusion Criteria: serious visual or visual perception problems orthopedic or other neurological problems occurred in recent 6 months 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: proximal robot-assisted therapy<br>treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system | Device: proximal robot-assisted therapy<br> <br> |
| Experimental: distal robot-assisted therapy<br>the InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination. | Device: distal robot-assisted therapy<br> <br> |
| Active Comparator: individualized intensive therapy<br>individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle. | Behavioral: individualized intensive therapy<br> <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, 2 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change scores of Box and block test (BBT) |  | baseline, 2 weeks, 4 weeks | 
| Change scores of Action research arm test (ARAT) |  | baseline, 2 weeks, 4 weeks | 
| Change scores of Medical Research Council scale (MRC) |  | baseline, 2 weeks, 4 weeks | 
| Change scores of Modified Ashworth scale (MAS) |  | baseline, 2 weeks, 4 weeks | 
| Change scores of Myoton |  | baseline, 4 weeks | 
| Change scores of Wolf Motor Function Test (WMFT) |  | baseline, 2 weeks, 4 weeks | 
| Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) |  | baseline, 4 weeks | 
| Change scores of Functional independent measure (FIM) |  | baseline, 2 weeks, 4 weeks | 
| Change scores of Stroke Impact Scale (SIS 3.0 version) |  | baseline, 2 weeks, 4 weeks | 
| Change scores of EuroQol Quality of Life Scale (EQ-5D) |  | baseline, 4 weeks | 
| Change scores of Hand strength |  | baseline, 2 weeks, 4 weeks | 
| Change scores of Motor activity log (MAL) |  | baseline, 4 weeks | 
| Change scores of ABILHAND Questionnaire |  | baseline, 4 weeks | 
| Change scores of 10-meter walking test |  | baseline, 4 weeks | 
| Change scores of Nottingham Extended ADL Questionnaire (NEADL) |  | baseline, 4 weeks | 
| Change scores of Adelaide Activities Profile (AAP) |  | baseline, 4 weeks | 
| Change scores of Montreal Cognitive Assessment (MoCA) |  | baseline, 4 weeks | 
| Change scores of Number stroop test |  | baseline, 4 weeks | 
| Change scores of Accelerometer |  | baseline, 4 weeks | 
| Change scores of Revised Nottingham Sensory Assessment (rNSA) |  | baseline, 4 weeks | 
| Change scores of Algometer |  | baseline, 4 weeks | 
| Change scores of kinematic analysis |  | baseline, 4 weeks | 
| Change scores of Adverse effects |  | baseline, 2 weeks, 4 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