Knee Biofeedback Rehabilitation Through Game Therapy

Official title

Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy

Overview

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.

Detailed description

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.

Interventions

• Device KneeBRIGHT System
  The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.
• Other Control Exercise
  The control group will complete a 10-week regimen of conventional PT exercise

Primary outcome measures

• Knee Osteoarthritis Outcome Score [Time frame: After 10 weeks (study completion)]
• Timed get-up-and-go score [Time frame: After 10 weeks (study completion)]
• 6-minute walk test [Time frame: After 10 weeks (study completion)]
• Quadriceps strength [Time frame: After 10 weeks (study completion)]
• Patient Activation Model Scores [Time frame: After 10 weeks (study completion)]

Secondary outcome measures (1)

• Patient technology acceptance [Time frame: After 10 weeks (study completion)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of North Carolina Chapel Hill — Chapel Hill

Publications

• 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: 10.1177/2753635126143582 PMID 41908080

Identifiers

NCT: NCT06090097 · KneeBRIGHT2B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗