Knee OsteoarthritisKneeBRIGHTNCT06090097
Knee Biofeedback Rehabilitation Through Game Therapy
A study testing KneeBRIGHT System in people with Knee Osteoarthritis, run by Barron Associates, Inc. at 1 site in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- KneeBRIGHT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Joe M Hart, PhD, 919-966-9166, joe_hart@med.unc.edu
Joe M Hart, PhD
About this study
Official title: Knee-Biofeedback Rehabilitation Interface for Game-based Home 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- KneeBRIGHT System, Control Exercise
- Keywords
- knee osteoarthritis, physical therapy, rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KneeBRIGHT SystemDevice
The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.
Control ExerciseOther
The control group will complete a 10-week regimen of conventional PT exercise
| Study group | Role | What they receive |
|---|---|---|
| KneeBRIGHT Group | Experimental | The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software. Receives: Device: KneeBRIGHT System |
| Control Group | Active comparator | The control group will conduct all exercises following a standard physical therapy regimen. Receives: Other: Control Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: After 10 weeks (study completion)
Quadriceps strength
Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer
Measured: 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
Measured: After 10 weeks (study completion)
Secondary outcomes (1)
Patient technology acceptance
Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance.
Measured: After 10 weeks (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start4 Sep 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barron Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Eileen Krepkovich, MS, Principal investigator, Barron Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090097
- Sponsor's protocol ID
- KneeBRIGHT2B
- Acronym
- KneeBRIGHT
- Status last verified
- Dec 2025
- First submitted
- 13 Oct 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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: 10.1177/27536351261435821. eCollection 2026 Jan-Dec.
PubMed 41908080
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy
- ClinicalTrials.gov ID
- NCT06090097
- Acronym / sponsor ID
- KneeBRIGHT / KneeBRIGHT2B
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, physical therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Barron Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| KneeBRIGHT Group | Experimental | Device: KneeBRIGHT SystemThe interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software. |
| Control Group | Active comparator | Other: Control ExerciseThe control group will conduct all exercises following a standard physical therapy regimen. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KneeBRIGHT SystemThe KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise. | Device | KneeBRIGHT Group |
| Control ExerciseThe control group will complete a 10-week regimen of conventional PT exercise | Other | Control Group |
Primary outcome
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
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.
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.
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
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
1 secondary outcome
Patient technology acceptance
Time frame: After 10 weeks (study completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 41908080Norbekov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eileen Krepkovich, MS principal investigator
Barron Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KneeBRIGHT System in people with Knee Osteoarthritis, run by Barron Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eileen Krepkovich, MS (4349731215 ext. 123, krepkovich@barronassociates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Osteoarthritis Outcome Score (time frame: After 10 weeks (study completion)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.