NCT03198845

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 23, 2017

Last Update Submit

June 23, 2017

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritisvideo gametherapeutic effects

Outcome Measures

Primary Outcomes (1)

  • change of Western Ontario and McMaster Universities Osteoarthritis index

    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 Outcomes (3)

  • change of quality of life

    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

    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

    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 Outcomes (5)

  • change of disability

    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

    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

    scores change from baseline to after 2 weeks of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated.

  • +2 more other outcomes

Study Arms (2)

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.

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.

Other: exercise

Interventions

video gameOTHER

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

video game
exerciseOTHER

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

exercise group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Knee operation history participants with pregnancy stroke history infection or fracture over lower limbs previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ru-Lan Hsieh, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 26, 2017

Study Start

August 1, 2014

Primary Completion

July 31, 2015

Study Completion

July 31, 2015

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)