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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

Tracking Information
First Submitted Date  ICMJE May 8, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2016)
  • Wolf Motor Function Test [ Time Frame: 4 weeks from baseline ]
  • Fugl-Meyer Assessment-hand & wrist [ Time Frame: 4 weeks from baseline ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
Wolf Motor Function Test [ Time Frame: 4 weeks from baseline ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Wolf Motor Function Test [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • 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.
  • 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
  • Stroke Impact Scale [ Time Frame: baseline, 4 weeks after baseline ]
  • Motor Activity Log [ Time Frame: baseline, 4 weeks after baseline ]
  • Medical research council scale of elbow flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Medical research council scale of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Range Of Motion of elbow flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Range Of Motion of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • 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
  • Jebsen-Taylor hand function test [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Modified Ashworth scale of elbow flexor/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Modified Ashworth scale of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Modified Tardieu scale of elbow flexor/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Modified Tardieu scale of wrist flexion/extension [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
  • Adverse events [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Any adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients
Official Title  ICMJE Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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
  • Device: Functional electrical stimulation
    Functional electrical stimulation on distal upper extremity
Study Arms  ICMJE
  • Experimental: Smart glove system with functional electrical stimulation
    game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity
    Intervention: Device: Smart glove system with functional electrical stimulation
  • Active Comparator: Functional electrical stimulation
    functional electrical stimulation on upper extremity
    Intervention: Device: Functional electrical stimulation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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+
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772510
Other Study ID Numbers  ICMJE NRC-2015-01-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
Study Sponsor  ICMJE National Rehabilitation Center, Seoul, Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center
PRS Account National Rehabilitation Center, Seoul, Korea
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP