Knee Biofeedback Rehabilitation Through Game Therapy

NCT06090097 | Recruiting DMC FDA Device

• 1 other identifier: KneeBRIGHT2B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

knee osteoarthritis, physical therapy, rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  After 10 weeks (study completion)

• Quadriceps strength

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

  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

  After 10 weeks (study completion)

Secondary Outcomes (1)

• Patient technology acceptance

  After 10 weeks (study completion)

Other Outcomes (1)

• Patient home exercise adherence

  After 10 weeks (study completion)

Study Arms (2)

KneeBRIGHT Group

EXPERIMENTAL

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

Device: KneeBRIGHT System

Control Group

ACTIVE COMPARATOR

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

Other: Control Exercise

Interventions

KneeBRIGHT System DEVICE

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

KneeBRIGHT Group

Control Exercise OTHER

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

Control Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barron Associates, Inc.: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41908080 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Eileen Krepkovich, MS

  Barron Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen Krepkovich, MS

CONTACT

4349731215; krepkovich@barronassociates.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers conducting functional outcomes on study completion will be blinded from the intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized control trial

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: September 4, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)