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

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ClinicalTrials.gov Identifier: NCT02772510
Recruitment Status : Unknown
Verified October 2016 by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Device: Smart glove system with functional electrical stimulation Device: Functional electrical stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Smart glove system with functional electrical stimulation
game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity
 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
Active Comparator: Functional electrical stimulation
functional electrical stimulation on upper extremity
 Device: Functional electrical stimulation
Functional electrical stimulation on distal upper extremity


Outcome Measures
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Primary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: 4 weeks from baseline ]
  2. Fugl-Meyer Assessment-hand & wrist [ Time Frame: 4 weeks from baseline ]

Secondary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  2. Box and Block Test [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    number of block transferred by hand from one box to other box.

  3. Fugl-Meyer Assessment upper extremity [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    global assessment of upper extremity impairment

  4. Stroke Impact Scale [ Time Frame: baseline, 4 weeks after baseline ]
  5. Motor Activity Log [ Time Frame: baseline, 4 weeks after baseline ]
  6. Medical research council scale of elbow flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  7. Medical research council scale of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  8. Range Of Motion of elbow flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  9. Range Of Motion of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  10. Brunnstrom stage [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    It represent the recovery status among stroke patients

  11. Jebsen-Taylor hand function test [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  12. Modified Ashworth scale of elbow flexor/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  13. Modified Ashworth scale of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  14. Modified Tardieu scale of elbow flexor/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  15. Modified Tardieu scale of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  16. Adverse events [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Any adverse events


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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+
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772510


Contacts
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Contact: Joon-Ho Shin, MS 82-2-901-1884 asfreelyas@gmail.com

Locations
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Korea, Republic of
National Rehabilitation Center Recruiting
Seoul, Korea, Republic of, 142884
Contact: Joon-Ho Shin, MS         
Principal Investigator: Joon-Ho Shin, MS         
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Investigators
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Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joon-Ho Shin, Manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT02772510    
Other Study ID Numbers: NRC-2015-01-004
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
Stroke
Rehabilitation
Hand
 Game
Functional electrical stimulation
Virtual reality
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases