Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

Study Overview
=================
Brief Summary
-----------------
Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)

Official Title
-----------------
Comparisons of Two Types of Rehabilitation Robot for Upper Extremities: 3 Dimension Exoskeleton Type Upper Extremity Robot vs. 2 Dimension End-effector Type Robot): Randomized Controlled Trial

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: 3D exoskeleton type robot
* Device: 2D end-effector type robot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Onset ≥ 3 months 8 ≤ Fugl-Meyer Assessment score ≤ 30 Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3 Cognitively intact enough to understand and follow the instructions from the investigator Exclusion Criteria: History of surgery of affected upper limb Fracture of affected upper limb

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D exoskeleton type robot<br>3 dimension exoskeleton type upper extremity robot | Device: 3D exoskeleton type robot<br>* 3 dimension exoskeleton type upper extremity robot<br>|
| Experimental: 2D end-effector type robot<br>2 dimension end-effector type upper extremity robot | Device: 2D end-effector type robot<br>* 2 dimension end-effector type upper extremity robot<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fugl-Meyer Assessment |  | Fugl-Meyer Assessment change from baseline at 4 weeks | 
| Wolf motor function test |  | Fugl-Meyer Assessment change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf motor function test |  | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Motor status score |  | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| medical research council scale of upper extremity |  | baseline | 
| Modified Ashworth scale of upeer extremity |  | baseline | 
| Pain of upper extremity | Pain complaints from participants | from baseline to 4 weeks after baseline | 
| Stroke impact scale |  | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Smoothness | Kinematics from Inmotion2 during point-to-point | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Reach Error | Kinematics from Inmotion2 during point-to-point | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Path Error | Kinematics from Inmotion2 during point-to-point | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Mean velocity | Kinematics from Inmotion2 during point-to-point | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Maximum velocity | Kinematics from Inmotion2 during point-to-point | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Cricle size | Kinematics from Inmotion2 during circle drawing | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Cricle independence | Kinematics from Inmotion2 during circle drawing | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Intrinsic motivation inventory |  | 4 weeks after baseline | 
| stroke rehabilitation motivation scale |  | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 
| Beck depression index |  | baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke