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

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

Tracking Information

• First Submitted Date: May 8, 2016
• First Posted Date: May 13, 2016
• Last Update Posted Date: October 25, 2016
• Study Start Date: February 2015
• Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: May 11, 2016): Wolf Motor Function Test [ Time Frame: 4 weeks from baseline ]

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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
• Device: Functional electrical stimulation
  Functional electrical stimulation on distal upper extremity

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 11, 2016): 54
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2016
• Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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+

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02772510
• Other Study ID Numbers: NRC-2015-01-004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
• Study Sponsor: National Rehabilitation Center, Seoul, Korea
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joon-Ho Shin, MS; National Rehabilitation Center

• PRS Account: National Rehabilitation Center, Seoul, Korea
• Verification Date: October 2016