Knee Biofeedback Rehabilitation Through Game Therapy

Knee Osteoarthritis Clinical Trial

— KneeBRIGHT  

Official title:

Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090097
• Other study ID #: KneeBRIGHT2B
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Barron Associates, Inc.
• Contact: Eileen Krepkovich, MS
• Phone: 4349731215
• Email: krepkovich[@]barronassociates.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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? 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Other:
• Control Exercise
The control group will complete a 10-week regimen of conventional PT exercise

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Barron Associates, Inc.	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient home exercise adherence	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	After 10 weeks (study completion)
Primary	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)
Primary	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)
Primary	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)
Primary	Quadriceps strength	Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer	After 10 weeks (study completion)
Primary	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	Patient technology acceptance	Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance.	After 10 weeks (study completion)