Osteo Arthritis Knee Clinical Trial
— KneeBRIGHTOfficial title:
Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") Phase II
Verified date | February 2023 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | July 28, 2021 |
Est. primary completion date | July 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | Barron Associates, Inc., National Institutes of Health (NIH) |
United States,
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* Note: There are 75 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS has 5 subscales: Symptoms, Pain, Sports, Activities of Daily Living (ADL) and quality of life (QOL). Each scale is expressed on a scale from 0-100 points where 100 = best perceived knee function and 0=worst perceived knee function. The outcome of this study is expressed as a change score from pre-post treatment where positive scores indicate an improvement on each KOOS subscale. | KOOS scores will be measured at baseline, day 1 and at the end of intervention, at 12 weeks. | |
Secondary | Change in Peak Torque of Thigh Muscles Strength Testing | Thigh muscle strength will be measured at baseline and follow up. Participants will be asked to perform thigh muscle (quadriceps / knee extension) contractions while measures of strength using a dynamometer (biodex system 4) are recorded. Participants will be asked to perform repeated, maximal muscle contractions to test knee extension muscle strength on the test limb (unilateral test, one thigh tested on each particiant). We recorded peak torque defined as the maximal torque achieved during knee extension contractions. The outcome score is expressed as a change in peak torque from pre-post treatment. Positive numbers indicate increases in strength. | Peak torque (muscle strength) will be measured at baseline, day 1 and at the end of intervention, at 12 weeks. |
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