Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: 3D exoskeleton type robot; Device: 2D end-effector type robot

• Registration Number: NCT03104881
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-10-23
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-01
• Study First Posted: 2017-04-07
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D exoskeleton type robot	3D exoskeleton type robot	3 dimension exoskeleton type upper extremity robot
2D end-effector type robot	2D end-effector type robot	2 dimension end-effector type upper extremity robot

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Motor status score	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Pain of upper extremity	from baseline to 4 weeks after baseline	Pain complaints from participants
Reach Error	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline	Kinematics from Inmotion2 during point-to-point
Path Error	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline	Kinematics from Inmotion2 during point-to-point
Mean velocity	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline	Kinematics from Inmotion2 during point-to-point
Cricle size	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline	Kinematics from Inmotion2 during circle drawing
Beck depression index	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Wolf motor function test	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
Stroke impact scale	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Smoothness	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline	Kinematics from Inmotion2 during point-to-point
Maximum velocity	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline	Kinematics from Inmotion2 during point-to-point
Cricle independence	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline	Kinematics from Inmotion2 during circle drawing
Intrinsic motivation inventory	4 weeks after baseline
stroke rehabilitation motivation scale	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of