The Effect of Application of Proximal and Distal Upper Rehabilitation Robot With Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Comparison of the effect of upper limb rehabilitation on the application of proximal upper rehabilitation robot and distal upper rehabilitation robot with stroke patients

Official Title
-----------------
The Effect of Upper Limb Rehabilitation on the Application of Proximal Upper Rehabilitation Robot and Distal Upper Rehabilitation Robot With Stroke Patients

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

Intervention / Treatment
-----------------
* Device: distal upper rehabilitation robot
* Device: proximal upper rehabilitation robot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Onset ≥ 3 months 29 ≤ Fugl-Meyer Assessment score 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: distal upper rehabilitation robot<br>experimental group that applied the distal upper rehabilitation robot | Device: distal upper rehabilitation robot<br>* Intervention with distal upper rehabilitation robot<br>|
| Other: proximal upper rehabilitation robot<br>control group that applied the proximal upper rehabilitation robot | Device: proximal upper rehabilitation robot<br>* Intervention with proximal upper rehabilitation robot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf motor function test | an activity indicator, has 15 items for testing functional ability | change from baseline at 4 weeks | 
| Fugl-Meyer Assessment | indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment | change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Motor activity log | Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Action reach arm test | to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Motor status score | evaluate the impairment level | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Box and block test | measures unilateral gross manual dexterity | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Wolf motor function test | an activity indicator, has 15 items for testing functional ability | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Mean velocity of upper extremity during reaching task | Mean velocity 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 | 
| Motor evoked potential over motor cortex of the affected side | Motor evoked potential elicited by noninvasive stimulation (rTMS) of the motor cortex | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke impact scale 3.0 | Total score and individual domain score of stroke impact scale | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 

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