Effects of Novel Game Rehabilitation System on Upper Extremity Function of Patients With Stroke

Stroke Clinical Trial

Official title:

Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02029651
• Other study ID #: NRC-2013-04-035
• Status: Unknown status
• Phase: N/A
• First received: January 1, 2014
• Last updated: April 13, 2015
• Start date: January 2014

Study information

• Verified date: April 2015
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 59
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• E-glove system
Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke

Procedure:
• Conventional occupational therapy
conventional occupational therapy

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea	Ministry of Trade, Industry & Energy, Republic of Korea, National IT Industry Promotion Agency, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-meyer assessment_upper extremity		Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention
Secondary	Fugl-meyer assessment_upper extremity		Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Secondary	Jebsen hand function test		Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Secondary	Purdue pegboard		Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Secondary	Stroke impact scale		Baseline, after 20th intervention
Secondary	Modified Ashworth scale of affected upper extremity		Baseline, after 20th intervention
Secondary	Medical research council scale of muscle strength of affected upper extremity		Baseline,after 20th intervention
Secondary	Satisfaction about intervention	only for the participants of E-glove intervention	after 20th intervention