- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03198845
Effects of Video Game on Patients With Knee Osteoarthritis
Therapeutic Effects Video Game Play Therapy on Patients With Knee Osteoarthritis: a Single Blind, Randomized-controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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. |
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. |
20-min per session for 3 times per week for a 4-week duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
|
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
|
scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
|
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
|
scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
|
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
|
scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
|
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
|
time change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
|
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
|
time change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST 103-2314-B-341-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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