Back to resultsEffects of Video Game on Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
video game
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, video game, therapeutic effects
Eligibility 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
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
video game
exercise group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
change of Western Ontario and McMaster Universities Osteoarthritis index
Western Ontario and McMaster Universities Osteoarthritis index
Secondary Outcome Measures
change of quality of life
World Health Organization-Quality of life-Brief Vision
change of emotion
Hospital Anxiety and Depression Scale
change of fatigue
Multidimensional Fatigue Inventory
Full Information
NCT ID
NCT03198845
First Posted
June 23, 2017
Last Updated
June 23, 2017
Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03198845
Brief Title
Effects of Video Game on Patients With Knee Osteoarthritis
Official Title
Therapeutic Effects Video Game Play Therapy on Patients With Knee Osteoarthritis: a Single Blind, Randomized-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
July 31, 2015 (Actual)
Study Completion Date
July 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, video game, therapeutic effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
video game
Arm Type
Active Comparator
Arm Description
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.
Arm Title
exercise group
Arm Type
Sham Comparator
Arm Description
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 Type
Other
Intervention Name(s)
video game
Intervention Description
20-min per session for 3 times per week for a 4-week duration
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
20-min per session for 3 times per week for a 4-week duration
Primary Outcome Measure Information:
Title
change of Western Ontario and McMaster Universities Osteoarthritis index
Description
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.
Secondary Outcome Measure Information:
Title
change of quality of life
Description
World Health Organization-Quality of life-Brief Vision
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.
Title
change of emotion
Description
Hospital Anxiety and Depression Scale
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.
Title
change of fatigue
Description
Multidimensional Fatigue Inventory
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.
Other Pre-specified Outcome Measures:
Title
change of disability
Description
Graded chronic pain scale
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.
Title
change of work ability
Description
Work ability 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.
Title
change of balance
Description
Biodex Stability System
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.
Title
change of stairs climbing time
Description
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.
Title
change of walking time
Description
walking 10-m 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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Video Game on Patients With Knee Osteoarthritis
We'll reach out to this number within 24 hrs