Adults 40 to 75, any sex, with Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)Primary· KOOS scores will be measured at baseline, day 1 and at the end of intervention, at 12 weeks.
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 Symptoms
Group
Value
95% CI
KneeBright Group
3.3
-.8 – 7.4
Standard Rehabilitation Group
8.9
4.7 – 13.2
KOOS Pain
Group
Value
95% CI
KneeBright Group
4.6
-2.2 – 11.5
Standard Rehabilitation Group
9.7
2.6 – 16.8
KOOS ADL
Group
Value
95% CI
KneeBright Group
6.4
-.9 – 13.6
Standard Rehabilitation Group
11.2
3.7 – 18.8
KOOS Sports
Group
Value
95% CI
KneeBright Group
8.7
-1 – 18.4
Standard Rehabilitation Group
16.4
6.4 – 26.5
KOOS QOL
Group
Value
95% CI
KneeBright Group
9.2
1.9 – 16.5
Standard Rehabilitation Group
9.8
2.3 – 17.4
Change in Peak Torque of Thigh Muscles Strength TestingSecondary· Peak torque (muscle strength) will be measured at baseline, day 1 and at the end of intervention, at 12 weeks.
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 tr
Extension peak torque 90degree
Group
Value
95% CI
KneeBright Group
0.11
-0.02 – 0.24
Standard Rehabilitation Group
0.11
-0.02 – 0.23
Extension peak torque 180 degree
Group
Value
95% CI
KneeBright Group
0.07
-0.13 – 0.27
Standard Rehabilitation Group
-0.06
-0.25 – 0.13
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07258693 — Multimodal Treatment of Knee Osteoarthritis: Therapeutic Exercise and Noninvasive Neuromodulation (NESA) Versus Therapeu
· NA
· active not recruiting
NCT07141316 — Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty
· NA
· active not recruiting
NCT06485843 — An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Jo
· Phase 2
· recruiting
NCT06965946 — Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis
· NA
· recruiting
NCT06058169 — Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2)
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Virginia
Last refreshed: 21 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04187092.