Recruiting

KneeBRIGHT

Sponsor:

Barron Associates, Inc.

Code:

NCT06090097

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

KneeBRIGHT System

Control Exercise

Study Details

Brief summary:

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.

Conditions

Knee Osteoarthritis

Study ID

NCT06090097

Start date

Sep 4, 2024

Status verified date

Dec, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KneeBRIGHT Group

The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software.

active comparator: Control Group

The control group will conduct all exercises following a standard physical therapy regimen.

Interventions

KneeBRIGHT System

The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.

Control Exercise

The control group will complete a 10-week regimen of conventional PT exercise

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Eileen Krepkovich, MS

4349731215krepkovich@barronassociates.com

Locations

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Joe M Hart, PhD

919-966-9166joe_hart@med.unc.edu

Principal Investigator:

Joe M Hart, PhD

More Information

Sponsor

Barron Associates, Inc.

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Keywords

  • knee osteoarthritis, physical therapy, rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barron Associates, Inc. on 2025-12-03.