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Effects of Video Game on Patients With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03198845
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Shin Kong Wu Ho-Su Memorial Hospital
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

Tracking Information
First Submitted Date  ICMJE June 23, 2017
First Posted Date  ICMJE June 26, 2017
Last Update Posted Date June 26, 2017
Actual Study Start Date  ICMJE August 1, 2014
Actual Primary Completion Date July 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
change of Western Ontario and McMaster Universities Osteoarthritis index [ Time Frame: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
Western Ontario and McMaster Universities Osteoarthritis index
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
  • change of quality of life [ Time Frame: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    World Health Organization-Quality of life-Brief Vision
  • change of emotion [ Time Frame: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    Hospital Anxiety and Depression Scale
  • change of fatigue [ Time Frame: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    Multidimensional Fatigue Inventory
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 23, 2017)
  • change of disability [ Time Frame: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    Graded chronic pain scale
  • change of work ability [ Time Frame: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    Work ability index
  • change of balance [ Time Frame: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    Biodex Stability System
  • change of stairs climbing time [ Time Frame: time change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    stairs climbing time
  • change of walking time [ Time Frame: time change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated. ]
    walking 10-m time
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Video Game on Patients With Knee Osteoarthritis
Official Title  ICMJE Therapeutic Effects Video Game Play Therapy on Patients With Knee Osteoarthritis: a Single Blind, Randomized-controlled Clinical Trial
Brief Summary To investigate the effects of video game play therapy in patients with knee osteoarthritis
Detailed Description

A total of 80 patients with knee osteoarthritis were randomized into two groups, including video game group and exercise group.

Physical activity, quality of life, emotion, and balance were assessed at before treatment and follow-up assessments, including at after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated, respectively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Other: video game
    20-min per session for 3 times per week for a 4-week duration
  • Other: exercise
    20-min per session for 3 times per week for a 4-week duration
Study Arms  ICMJE
  • Active Comparator: video game

    Participants received a total of twelve 40-min sessions of hot pack therapy combined transcutaneous electrical nerve simulation over the knees followed by 20-min supervised video game play therapy 20-min per session for 3 times per week for a 4-week duration.

    Therapeutic effects of video game intervention for patients with knee osteoarthritis were assessed.

    Intervention: Other: video game
  • Sham Comparator: exercise group

    Participants received a total of twelve 40-min sessions of hot pack therapy combined transcutaneous electrical nerve simulation over the knees followed by 20-min supervised therapeutic exercise 20-min per session for 3 times per week for a 4-week duration.

    Therapeutic effects of therapeutic exercise for patients with knee osteoarthritis were assessed.

    Intervention: Other: exercise
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2017)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2015
Actual Primary Completion Date July 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Knee osteoarthritis with Kellgren/Lawrence grade II of greater ambulatory for more than 15 meters without support or orthosis usage

Exclusion Criteria:

  • Knee operation history participants with pregnancy stroke history infection or fracture over lower limbs previously
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (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 Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03198845
Other Study ID Numbers  ICMJE MOST 103-2314-B-341-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ru-Lan Hsieh, Taipei Medical University
Study Sponsor  ICMJE Taipei Medical University
Collaborators  ICMJE Shin Kong Wu Ho-Su Memorial Hospital
Investigators  ICMJE
Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital
PRS Account Taipei Medical University
Verification Date June 2017

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