Knee Biofeedback Rehabilitation Through Game Therapy
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorBarron Associates, Inc.
About this trial
The goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis. The main question the study aims to answer is: do patients who exercise with the game have better functional outcomes and engagement compared to patients who do conventional exercise? Participants will complete 10 weeks of physical therapy exercise sessions that focus on quadriceps strengthening. Two sessions per week will be conducted in the clinic, and one session will be conducted at home each week. The interventional group will conduct all exercises using the KneeBRIGHT EMG sensors and game software. The control group will conduct all exercises following a standard physical therapy regimen. Researchers will compare knee function and engagement between the group who uses the game, and the group who does conventional exercise.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis via x-ray, with a score of at least 2 (out of 4) on the Kellgren-Lawrence OA scoring system; independent ambulation without assistive device
Disqualifiers
individuals who have psychiatric or cognitive impairment (e.g., dementia) that interferes with their ability to follow instructions or provide voluntary consent; symptomatic spine, hip, ankle, or foot disease other than OA that would interfere with assessment of the knee.
Trial design
Design model
Parallel
Treatments tested in this trial
KneeBRIGHT System
DeviceThe KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.
Control Exercise
Other interventionThe control group will complete a 10-week regimen of conventional PT exercise
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: KneeBRIGHT GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Knee Osteoarthritis Outcome Score
A multi-dimensional assessment that classifies knee outcomes into five categories: pain, symptoms, activities of daily living (ADL), sport, and quality of life
Time frame
After 10 weeks (study completion)2
Timed get-up-and-go score
In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Time frame
After 10 weeks (study completion)3
6-minute walk test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
Time frame
After 10 weeks (study completion)4
Quadriceps strength
Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer
Time frame
After 10 weeks (study completion)Secondary outcomes
1
Patient technology acceptance
Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance.
Time frame
After 10 weeks (study completion)Other outcomes
1
Patient home exercise adherence
The KneeBRIGHT software will log the exercises completed at home; these logs will report number of exercises conducted, level of resistance, and timestamps for the sessions. Control group participants will log home exercises using a written checklist of exercises
Time frame
After 10 weeks (study completion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Barron Associates, Inc.
Lead sponsor
University of North Carolina, Chapel Hill
Collaborator
Source ClinicalTrials.gov