Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients

Stroke Clinical Trial

Official title:

Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772510
• Other study ID #: NRC-2015-01-004
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2016
• Last updated: October 23, 2016
• Start date: February 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin, MS
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• first-ever ischemic or hemorrhagic stroke

• wrist extensor of medical research council scale 1~3

• No clinical evidence of limited passive range of motion of affected wrist

Exclusion Criteria:

• age <18 years

• severe aphasia resulting in communication difficulties confounding intervention and outcome measures

• severe cognitive impairment resulting cooperation difficulties

• spasticity > modified Ashworth scale 1+

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Smart glove system with functional electrical stimulation
Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity
• Functional electrical stimulation
Functional electrical stimulation on distal upper extremity

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wolf Motor Function Test		4 weeks from baseline	No
Primary	Fugl-Meyer Assessment-hand & wrist		4 weeks from baseline	No
Secondary	Wolf Motor Function Test		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Box and Block Test	number of block transferred by hand from one box to other box.	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Fugl-Meyer Assessment upper extremity	global assessment of upper extremity impairment	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Stroke Impact Scale		baseline, 4 weeks after baseline	No
Secondary	Motor Activity Log		baseline, 4 weeks after baseline	No
Secondary	Medical research council scale of elbow flexion/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Medical research council scale of wrist flexion/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Range Of Motion of elbow flexion/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Range Of Motion of wrist flexion/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Brunnstrom stage	It represent the recovery status among stroke patients	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Jebsen-Taylor hand function test		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Modified Ashworth scale of elbow flexor/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Modified Ashworth scale of wrist flexion/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Modified Tardieu scale of elbow flexor/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Modified Tardieu scale of wrist flexion/extension		baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	No
Secondary	Adverse events	Any adverse events	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Yes