Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy for Patients With Knee Osteoarthritis (KneeBRIGHT)
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|ClinicalTrials.gov Identifier: NCT04187092|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
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, thigh muscle strength, and balance. 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.
|Condition or disease||Intervention/treatment||Phase|
|Osteo Arthritis Knee||Other: KneeBright Group Other: Standard Rehabilitation group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Participants with knee osteoarthritis will be randomly assigned to Group 1 or 2. During each exercise session all the participants will perform stretching exercises, strengthening exercises and balance exercises. Dosage of exercises will be based on the rehabilitation principles and will be guided and progressed the way the participants feel about their knee health throughout the rehabilitation program.
Participants in Group1 (KneeBright group), will perform some of the exercises with the KneeBright Device and while playing a video game, while Group 2 will undergo standard knee rehabilitation exercises without the KneeBright device.
Both groups will undergo a 12 week program including 3 exercise sessions per week that include a combination of in-person and at home sessions. Participants in both groups will undergo 36 exercise sessions in total, each lasting for 1 hour. Among these 36 sessions 20 will be performed in clinic under supervision and 16 will be performed at home.
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessors will be blinded and will be responsible for executing the baseline and follow-up outcome measures. Assessors have the adequate training and experience for recording the patient reported outcome measures along with conducting the thigh muscle strength and balance testing.|
|Official Title:||Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") Phase II|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: KneeBright group
Participants in this group will perform exercises aimed to improve the muscle strength, balance and precision. Participants will perform exercises three times a week for 12 weeks. Each session will last for an hour. Some of the exercises will be performed with the KneeBright Device while playing a video game.
Other: KneeBright Group
The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
The KneeBRIGHT software will incorporates a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions.
Active Comparator: Standard Rehabilitation group
Participants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device.
Other: Standard Rehabilitation group
Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
- Change in Knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: KOOS scores will be measured at baseline, day 1 and at the end of intervention, at 12 weeks. ]Knee function will be assessed by composite KOOS score prior to the study and will be compared to the KOOS score recorded post-intervention to test the primary hypothesis that patients conducting the KneeBRIGHT exercise will significantly improve knee function compared to the control group. Pre-intervention KOOS scores measures will be subtracted from the post-intervention scores.
- Change in Peak torque of hip and thigh muscles strength testing [ Time Frame: 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 contractions while measures of strength using a dynamometer (biodex system 4) are recorded.
Participants will be asked to perform repeated, maximal muscle contractions bilaterally to test muscle strength and endurance of the hip and thigh muscles (knee flexion and extension, hip abduction and adduction). This test takes 25 minutes to complete.
- Change in Balance performance [ Time Frame: Balance will be tested at baseline, day 1 and at the end of intervention, at 12 weeks. ]Bilateral balance performance will be tested at the baseline and follow up. Participants will be asked to stand on a pressure mat for 30 seconds while balance measures are recorded. Participants will be asked to perform 2 repetitions on both right and left sides. Testing is performed by a blinded investigator with experience and training to perform these measures in patients with knee injuries.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187092
|Contact: Joseph M Hart, PhD||434 243 firstname.lastname@example.org|
|Contact: Mandeep Kaur, PhDemail@example.com|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Contact: Jospeph Hart, PhD 434-243-0256 Jmh3zf@virginia.edu|
|Principal Investigator: Susan Saliba, PhD|
|Principal Investigator: Joesph Hart, PhD|
|Sub-Investigator: Eileen Krepkovich|
|Sub-Investigator: William Gressick|
|Sub-Investigator: Matthew Lichter|
|Sub-Investigator: Aaron Olowin|
|Sub-Investigator: Jeames Patrie|
|Sub-Investigator: Neal Richardson|
|Sub-Investigator: Christina Tieu|
|Principal Investigator:||Joseph M Hart, PhD||University of Virginia|