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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

Brief Summary:
To investigate the effects of video game play therapy in patients with knee osteoarthritis

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: video game Other: exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Effects Video Game Play Therapy on Patients With Knee Osteoarthritis: a Single Blind, Randomized-controlled Clinical Trial
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : July 31, 2015
Actual Study Completion Date : July 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.

Other: video game
20-min per session for 3 times per week for a 4-week duration

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.

Other: exercise
20-min per session for 3 times per week for a 4-week duration




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03198845


Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111-01
Sponsors and Collaborators
Taipei Medical University
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
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Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital

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Responsible Party: Ru-Lan Hsieh, Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT03198845     History of Changes
Other Study ID Numbers: MOST 103-2314-B-341-002
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
knee osteoarthritis
video game
therapeutic effects
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases