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NCT Number: NCT06090097

Knee Biofeedback Rehabilitation Through Game Therapy

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Carla Hill, DPT

SUB_INVESTIGATOR

Joe M Hart, PhD

CONTACT

[email protected]

919-966-9166

Joe M Hart, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KneeBRIGHT System

Device

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

Control Exercise

Other

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

Primary outcomes

  1. Knee Osteoarthritis Outcome Score

    Time frame: After 10 weeks (study completion)

    A multi-dimensional assessment that classifies knee outcomes into five categories: pain, symptoms, activities of daily living (ADL), sport, and quality of life

  2. Timed get-up-and-go score

    Time frame: After 10 weeks (study completion)

    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.

  3. 6-minute walk test

    Time frame: After 10 weeks (study completion)

    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.

  4. Quadriceps strength

    Time frame: After 10 weeks (study completion)

    Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer

  5. Patient Activation Model Scores

    Time frame: After 10 weeks (study completion)

    The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens

Secondary outcomes

  1. Patient technology acceptance

    Time frame: After 10 weeks (study completion)

    Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance.

Other outcomes

  1. Patient home exercise adherence

    Time frame: After 10 weeks (study completion)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Eileen Krepkovich, MS

CONTACT

[email protected]

4349731215 ext. 123

Sponsors and collaborators

Lead sponsor

Barron Associates, Inc.

Industry

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy

Acronym: KneeBRIGHT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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