Knee Biofeedback Rehabilitation Through Game Therapy

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Barron Associates, Inc.
Study ID
NCT06090097
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • KneeBRIGHT System — DEVICE
    The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.
  • Control Exercise — OTHER
    The control group will complete a 10-week regimen of conventional PT exercise

Study Details

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.

Key Dates

Start date
Sep 4, 2024
Status verified
Dec 2025
Primary completion
Nov 1, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KneeBRIGHT Group
    The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software.
  • Active Comparator: Control Group
    The control group will conduct all exercises following a standard physical therapy regimen.

Primary Outcome Measure

Knee Osteoarthritis Outcome Score [ Time Frame: After 10 weeks (study completion) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina Chapel HillChapel HillNorth Carolina27599
Joe M Hart, PhD
919-966-9166
Joe M Hart, PhD (PRINCIPAL_INVESTIGATOR)
Carla Hill, DPT (SUB_INVESTIGATOR)

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