N/A
N=34
Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy for Patients With Knee Osteoarthritis
Osteo Arthritis Knee
Bottom Line
View on ClinicalTrials.gov: NCT04187092 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) — 3.3; 8.9; 4.6; 9.7 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- KneeBright Group (Other); Standard Rehabilitation group (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) |
3.3; 8.9; 4.6; 9.7; 6.4; 11.2 | <0.05 sig |
| SECONDARY Change in Peak Torque of Thigh Muscles Strength Testing |
0.11; 0.11; 0.07; -0.06 | — |
Summary
Osteoarthritis (OA) is the leading cause of disability in the United States. As osteoarthritis is associated with the lower limb muscle weakness, rehabilitation through quadriceps strengthening is a well-established treatment for patients with knee OA, but patient adherence to exercise routines is low due to lack of guidance regarding optimal protocols and lack of engagement during the repetitive routines that patients find tedious and boring.
The Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") system combines electromyography (EMG) biofeedback with video game therapy to provide knee OA patients with an engaging, effective tool for conducting rehabilitation exercises at home. KneeBRIGHT aims to motivate patients with knee OA to conduct regular muscle strengthening exercise through an engaging, EMG-driven video game therapy.
Overall goal of the program is to improve knee OA outcomes through effective and motivating rehabilitation exercises. Participants will be randomized to two groups: (1) KneeBRIGHT group; (2) Standard rehabilitation group. Both groups will undergo baseline and follow up assessment to measure the patient-reported outcomes and thigh muscle strength. Participants in both groups will undergo a 12-week program including 3 exercise sessions per week that includes a combination of in-person and at home sessions. Pre and post intervention outcome measures will be compared to explore the effectiveness. Technology acceptance will also be studied in patients randomized to KneeBRIGHT group.
Eligibility Criteria
Inclusion Criteria
- Age 40-75
- Diagnosis of Osteoarthritis
- 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 osteoarthritis that would interfere with assessment of the knee.
- Balance or vestibular disorders
- Peripheral neuropathy
- Skin conditions that prevent EMG electrode placement
- Prisoner
- Pregnant (by report)
- Non-English-speaking
- Individuals who are visually and/or hearing impaired
Data sourced from ClinicalTrials.gov (NCT04187092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.