Knee OsteoarthritisNCT03198845
Effects of Video Game on Patients With Knee Osteoarthritis
A study testing video game and exercise in people with Knee Osteoarthritis, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
To investigate the effects of video game play therapy in patients with knee osteoarthritis Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- video game and exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2014to 31 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis with Kellgren/Lawrence grade II of greater ambulatory for more than 15 meters without support or orthosis usage
Who cannot join
- Knee operation history participants with pregnancy stroke history infection or fracture over lower limbs previously
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects Video Game Play Therapy on Patients With Knee Osteoarthritis: a Single Blind, Randomized-controlled Clinical Trial
To investigate the effects of video game play therapy in patients with knee osteoarthritis
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- video game, exercise
- Keywords
- knee osteoarthritis, video game, therapeutic effects
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video gameOther
20-min per session for 3 times per week for a 4-week duration
exerciseOther
20-min per session for 3 times per week for a 4-week duration
| Study group | Role | What they receive |
|---|---|---|
| video game | Active comparator | 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. Receives: Other: video game |
| exercise group | Sham comparator | 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. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Western Ontario and McMaster Universities Osteoarthritis index
Western Ontario and McMaster Universities Osteoarthritis index
Measured: 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 outcomes (3)
change of quality of life
World Health Organization-Quality of life-Brief Vision
Measured: 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
Hospital Anxiety and Depression Scale
Measured: 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
Multidimensional Fatigue Inventory
Measured: scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Aug 2014
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198845
- Sponsor's protocol ID
- MOST 103-2314-B-341-002
- Status last verified
- Jun 2017
- First submitted
- 23 Jun 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects Video Game Play Therapy on Patients With Knee Osteoarthritis: a Single Blind, Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03198845
- Acronym / sponsor ID
- MOST 103-2314-B-341-002
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, video game, therapeutic effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video game | Active comparator | Other: video gameParticipants 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. |
| exercise group | Sham comparator | Other: exerciseParticipants 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Knee osteoarthritis with Kellgren/Lawrence grade II of greater ambulatory for more than 15 meters without support or orthosis usage
Key exclusion criteria (1 listed)
- Knee operation history participants with pregnancy stroke history infection or fracture over lower limbs previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video game20-min per session for 3 times per week for a 4-week duration | Other | video game |
| exercise20-min per session for 3 times per week for a 4-week duration | Other | exercise group |
Primary outcome
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
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video game and exercise in people with Knee Osteoarthritis, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.