Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
Not provided
Not provided
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.
The KneeBRIGHT game system will be evaluated in a 10-week single-blinded randomized controlled trial. The goals of this study are to: (1) assess improvements in functional outcomes following an exercise regimen conducted by KneeBRIGHT compared to conventional exercise; and (2) evaluate patient engagement during unsupervised, home-based exercises with and without the KneeBRIGHT software. Over the course of the study period, the knee OA participants will conduct physical therapy sessions with the physical therapist (PT) who enrolled them. The exercise regimen will implement each PT's standard of care, consisting of two weekly clinic sessions and one weekly home exercise session, for 10 weeks. Knee OA participants will be randomly assigned (via block randomization for each PT) to use either the KneeBRIGHT system for both clinic and home exercise, or to receive standard care with conventional exercise routines. Participants will conduct functional exercise assessments on study intake and again on study completion. Participants will also complete questionnaires focused on exercise engagement on study completion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KneeBRIGHT Group | Experimental | The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software. |
|
| Control Group | Active Comparator | The control group will conduct all exercises following a standard physical therapy regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KneeBRIGHT System | Device | The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 10 weeks (study completion) |
| 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. | After 10 weeks (study completion) |
| 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. | After 10 weeks (study completion) |
| Quadriceps strength | Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer | After 10 weeks (study completion) |
| Patient Activation Model Scores | The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens | After 10 weeks (study completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient technology acceptance | Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance. | After 10 weeks (study completion) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 10 weeks (study completion) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eileen Krepkovich, MS | Contact | 4349731215 | 123 | krepkovich@barronassociates.com |
| Name | Affiliation | Role |
|---|---|---|
| Eileen Krepkovich, MS | Barron Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41908080 | Derived | Norbekov A, Krepkovich E, Hill C, Berkoff D, Adams N, Kelly DK, Jackman A, Kane J, Hanson A, Hart JM. Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy (KneeBRIGHT) in Patients with Knee Osteoarthritis: A Protocol for Evaluating the KneeBRIGHT System via Randomized, Controlled Clinical Trial. Adv Rehabil Sci Pract. 2026 Mar 27;15:27536351261435821. doi: 10.1177/27536351261435821. eCollection 2026 Jan-Dec. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
randomized control trial
Not provided
Not provided
Researchers conducting functional outcomes on study completion will be blinded from the intervention group.
| Control Exercise | Other | The control group will complete a 10-week regimen of conventional PT exercise |
|
| D012216 |
| Rheumatic Diseases |