Clinical trial NCT06090097: Knee Biofeedback Rehabilitation Through Game Therapy
Official title: Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis, physical therapy, rehabilitation
Lead sponsor: Barron Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2023-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Osteoarthritis Outcome Score
timeFrame: After 10 weeks (study completion)
measure: Timed get-up-and-go score
timeFrame: After 10 weeks (study completion)
measure: 6-minute walk test
timeFrame: After 10 weeks (study completion)
measure: Quadriceps strength
timeFrame: After 10 weeks (study completion)
measure: Patient Activation Model Scores
timeFrame: After 10 weeks (study completion)
Secondary outcomes:
measure: Patient technology acceptance
timeFrame: After 10 weeks (study completion)
Other outcomes:
measure: Patient home exercise adherence
timeFrame: After 10 weeks (study completion)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: Barron Associates
name: Eileen Krepkovich, MS
role: PRINCIPAL_INVESTIGATOR
References: