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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Smart glove system with functional electrical stimulation
Functional electrical stimulation
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Hand, Game, Functional electrical stimulation, Virtual reality

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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+

Sites / Locations

  • National Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smart glove system with functional electrical stimulation

Functional electrical stimulation

Arm Description

game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity

functional electrical stimulation on upper extremity

Outcomes

Primary Outcome Measures

Wolf Motor Function Test
Fugl-Meyer Assessment-hand & wrist

Secondary Outcome Measures

Wolf Motor Function Test
Box and Block Test
number of block transferred by hand from one box to other box.
Fugl-Meyer Assessment upper extremity
global assessment of upper extremity impairment
Stroke Impact Scale
Motor Activity Log
Medical research council scale of elbow flexion/extension
Medical research council scale of wrist flexion/extension
Range Of Motion of elbow flexion/extension
Range Of Motion of wrist flexion/extension
Brunnstrom stage
It represent the recovery status among stroke patients
Jebsen-Taylor hand function test
Modified Ashworth scale of elbow flexor/extension
Modified Ashworth scale of wrist flexion/extension
Modified Tardieu scale of elbow flexor/extension
Modified Tardieu scale of wrist flexion/extension
Adverse events
Any adverse events

Full Information

First Posted
May 8, 2016
Last Updated
October 23, 2016
Sponsor
National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02772510
Brief Title
Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Hand, Game, Functional electrical stimulation, Virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smart glove system with functional electrical stimulation
Arm Type
Experimental
Arm Description
game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity
Arm Title
Functional electrical stimulation
Arm Type
Active Comparator
Arm Description
functional electrical stimulation on upper extremity
Intervention Type
Device
Intervention Name(s)
Smart glove system with functional electrical stimulation
Intervention Description
Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation
Intervention Description
Functional electrical stimulation on distal upper extremity
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Time Frame
4 weeks from baseline
Title
Fugl-Meyer Assessment-hand & wrist
Time Frame
4 weeks from baseline
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Box and Block Test
Description
number of block transferred by hand from one box to other box.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Fugl-Meyer Assessment upper extremity
Description
global assessment of upper extremity impairment
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Stroke Impact Scale
Time Frame
baseline, 4 weeks after baseline
Title
Motor Activity Log
Time Frame
baseline, 4 weeks after baseline
Title
Medical research council scale of elbow flexion/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Medical research council scale of wrist flexion/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Range Of Motion of elbow flexion/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Range Of Motion of wrist flexion/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Brunnstrom stage
Description
It represent the recovery status among stroke patients
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Jebsen-Taylor hand function test
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Modified Ashworth scale of elbow flexor/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Modified Ashworth scale of wrist flexion/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Modified Tardieu scale of elbow flexor/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Modified Tardieu scale of wrist flexion/extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Adverse events
Description
Any adverse events
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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+
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon-Ho Shin, MS
Phone
82-2-901-1884
Email
asfreelyas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29505744
Citation
Lee SH, Lee JY, Kim MY, Jeon YJ, Kim S, Shin JH. Virtual Reality Rehabilitation With Functional Electrical Stimulation Improves Upper Extremity Function in Patients With Chronic Stroke: A Pilot Randomized Controlled Study. Arch Phys Med Rehabil. 2018 Aug;99(8):1447-1453.e1. doi: 10.1016/j.apmr.2018.01.030. Epub 2018 Mar 2.
Results Reference
derived

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

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