Barron Associates, Inc.
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.
Knee Osteoarthritis
KneeBRIGHT System
Control Exercise
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 60 participants |
| Masking : | SINGLE |
| Masking Description : | Researchers conducting functional outcomes on study completion will be blinded from the intervention group. |
| Primary Purpose : | TREATMENT |
| Official Title : | Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy |
| Actual Study Start Date : | 2024-09 |
| Estimated Primary Completion Date : | 2025-03 |
| Estimated Study Completion Date : | 2025-04 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 30 Years to 75 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599