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

National Rehabilitation Center, Seoul, Korea1 site in 1 country40 target enrollmentApril 2015

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: National Rehabilitation Center, Seoul, Korea
Enrollment: 40
Locations: 1
Primary Endpoint: Change of Fugl-Meyer Assessment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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)

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

March 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Rehabilitation Center, Seoul, Korea

Responsible Party

Principal Investigator

Joon-Ho Shin

Team manager

National Rehabilitation Center, Seoul, Korea

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

Outcomes

Primary Outcomes

Change of Fugl-Meyer Assessment

Time Frame: Fugl-Meyer Assessment change from baseline at 4 weeks

Wolf motor function test

Time Frame: Fugl-Meyer Assessment change from baseline at 4 weeks

Secondary Outcomes

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)
Reach Error(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
Path Error(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
Mean velocity(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
Cricle size(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)
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)
Maximum velocity(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
Cricle independence(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)