Knee Biofeedback Rehabilitation Through Game Therapy

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: KneeBRIGHT System; Other: Control Exercise

• Registration Number: NCT06090097
• Lead Sponsor: Barron Associates, Inc.

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.

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 Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Study Start: 2024-09-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KneeBRIGHT Group	KneeBRIGHT System	The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software.
Control Group	Control Exercise	The control group will conduct all exercises following a standard physical therapy regimen.

Primary Outcome Measures

Name	Time	Method
Patient Activation Model Scores	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
Knee Osteoarthritis Outcome Score	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	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	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	After 10 weeks (study completion)	Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer

Secondary Outcome Measures

Name	Time	Method
Patient technology acceptance	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.

Trial Locations

Locations (1)

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States