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Recruiting Not applicable

Knee Biofeedback Rehabilitation Through Game Therapy

NCT06090097 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2024-09-04
Last updated
2025-12-03

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

KneeBRIGHT SystemControl Exercise

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

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

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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
  • 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

Trial sites (1)

FacilityCityRegionStatus
University of North Carolina Chapel Hill Chapel Hill North Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06090097 on ClinicalTrials.gov ↗ ← All trials in the USA