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Knee Biofeedback Rehabilitation Through Game Therapy

NCT ID: NCT06090097

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Knee Osteoarthritis

Keywords

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knee osteoarthritis, physical therapy, rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Researchers conducting functional outcomes on study completion will be blinded from the intervention group.

Study Groups

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KneeBRIGHT Group

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

Group Type EXPERIMENTAL

KneeBRIGHT System

Intervention Type DEVICE

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

Control Group

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

Group Type ACTIVE_COMPARATOR

Control Exercise

Intervention Type OTHER

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

Interventions

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KneeBRIGHT System

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

Intervention Type DEVICE

Control Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Barron Associates, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eileen Krepkovich, MS

Role: PRINCIPAL_INVESTIGATOR

Barron Associates

Locations

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University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eileen Krepkovich, MS

Role: CONTACT

Phone: 4349731215

Email: [email protected]

Facility Contacts

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Joe M Hart, PhD

Role: primary

Other Identifiers

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KneeBRIGHT2B

Identifier Type: -

Identifier Source: org_study_id