Comparisons of Two Types of Armeo Robot for Upper Extremities

Study Overview
=================
Brief Summary
-----------------
Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function

Detailed Description
-----------------
The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist. Thus the results from this study might suggest usefulness of motorized robot.

Official Title
-----------------
Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Device: Armeo power
* Device: Armeo spring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Onset ≥ 3 months 26 ≤ Fugl-Meyer Assessment score ≤ 50 3 ≤ Shoulder or elbow MRC scale ≤ 4 Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+ 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: 19 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: Armeo power<br>Armeo power robot for upper extremity | Device: Armeo power<br>* Intervention with Armeo power rehabilitation robot for upper extremity (made by Hocoma), which provide assistive force. The intervention was done 4 weeks, 5 times/week, 30 minutes/day.<br>|
| Experimental: Armeo spring<br>Armeo spring robot for upper extremity | Device: Armeo spring<br>* Intervention with Armeo spring rehabilitation robot for upper extremity (made by Hocoma), which is operated only by participants, without any assistive force from robot. The intervention was done 4 weeks, 5 times/week, 30 minutes/day.<br>|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | Fugl-Meyer Assessment | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke impact scale | Stroke impact scale (Health-related quality of life measurements in stroke patients) | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Motor activity log | Motor activity log | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Mean velocity of upper extremity during reaching task | Curvature of the magnetic sensor trajectory (Kinematics of upper extremity)during reaching task | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Curvature of upper extremity during reaching task | Curvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Jerk of upper extremity during reaching task | Jerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| % maximal voluntary contraction of upper extremity muscles during reaching task | surface EMG of upper extremity during reaching task | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Behavioral activation system/behavioral inhibition system scale | Behavioral activation system subscale, behavioral inhibition system subscale | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Beck depression index | Beck depression index | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Intrinsic motivation inventory | Intrinsic motivation inventory | baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke rehabilitation motivation scale | Stroke rehabilitation motivation scale | baseline, 4 weeks after baseline, 8 weeks after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, upper extremity rehabilitation robot, stroke rehabilitation