Overview

This trial is active, not recruiting.

Condition stroke
Treatments e-glove system, conventional occupational therapy
Sponsor National Rehabilitation Center, Seoul, Korea
Collaborator Ministry of Trade, Industry & Energy, Republic of Korea
Start date January 2014
End date April 2015
Trial size 59 participants
Trial identifier NCT02029651, NRC-2013-04-035

Summary

The purpose of this study is to determine whether novel upper extremity rehabilitation system for patients with stroke(e-glove system) are effective in the rehabilitation compared to conventional occupational therapy

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
E-glove rehabilitation system for upper extremity
e-glove system
Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke
(Active Comparator)
conventional occupational therapy
conventional occupational therapy
conventional occupational therapy

Primary Outcomes

Measure
Fugl-meyer assessment_upper extremity
time frame: Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention

Secondary Outcomes

Measure
Fugl-meyer assessment_upper extremity
time frame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Jebsen hand function test
time frame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Purdue pegboard
time frame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Stroke impact scale
time frame: Baseline, after 20th intervention
Modified Ashworth scale of affected upper extremity
time frame: Baseline, after 20th intervention
Medical research council scale of muscle strength of affected upper extremity
time frame: Baseline,after 20th intervention
Satisfaction about intervention
time frame: after 20th intervention

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Hemiplegic stroke patients - Medical research council scale >= 2 of finger or wrist flexor/extensor - Medical research council scale >= 2 of elbow pronation/supination Exclusion Criteria: - Bilateral weakness of upper extremities - Uncontrolled medical or surgical illness - Predisposing psychological or neurological disorders - Severe aphasia unable to communicate - Severe cognitive impairment not to cooperate - Severe pain impeding upper extremity rehabilitation

Additional Information

Official title Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial
Principal investigator Joon-Ho Shin
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by National Rehabilitation Center, Seoul, Korea.