Osteo Arthritis KneeKneeBRIGHTNCT04187092
Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy for Patients With Knee Osteoarthritis
A study testing KneeBright Group and Standard Rehabilitation group in people with Osteo Arthritis Knee, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- KneeBright Group and Standard Rehabilitation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 28 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75
- Diagnosis of Osteoarthritis
- Independent ambulation without assistive device
Who cannot join
- 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
Show all 9Show fewer
- Pregnant (by report)
- Non-English-speaking
- Individuals who are visually and/or hearing impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") Phase II
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.
Read the detailed description
Osteoarthritis (OA) is the leading cause of disability in the United States. As osteoarthritis is associated with the lower limb muscle weakness, rehabilitation focused on quadriceps and other lower extremity muscle strengthening is a well-established treatment for patients with knee OA. However, patient adherence to exercise routines is low due to the lack of guidance regarding optimal protocols, and poor engagement during the repetitive routines that patients find tedious and boring.
Long-term goal of this study is to improve knee OA outcomes through effective and motivating rehabilitation exercises. The Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") system combines electromyography (EMG) biofeedback with video game therapy (VGT) 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.
Participants with age from 40-75, with independent ambulation and with the diagnosis of knee OA made by x-ray and a score of at least 2 (out of 4) on the Kellgren-Lawrence OA radiographic classification system will be included in the study. Participants with psychiatric or cognitive impairment (e.g., dementia), symptomatic spine, hip, ankle, or foot disease other than OA that would interfere with assessment of the knee will be excluded. Participants with balance or vestibular disorders, peripheral neuropathy, skin conditions that prevent EMG electrode placement, prisoner, pregnant women (by report), non-English-speaking, individuals who are visually and/or hearing impaired will also be excluded.
Eligible 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
Both groups will undergo same rehabilitation protocol which will begin with sessions supervised in the clinic by the study team physical therapist and gradually home sessions will be added. Participants in KneeBRIGHT group will perform the quadriceps strengthening exercises with the video-games based activities. The EMG biofeedback units and video game w/laptop will be provided to the subjects for home use. Subjects will receive instruction on how to apply the EMG biofeedback unit and use of the video game. KneeBRIGHT Game Activities consists of an introduction of the player to the virtual world and the missions, the player customizes the personal avatar and completes a series of calibration contractions and practice exercises to gain familiarity with the game controls. Through the EMG system, a player's muscle contractions translate into physical movements of the avatar and control of vehicles within the virtual environment. Each quest-type challenge is designed to permit play in a seated, supine, supported standing, or freestanding position, based on an individual's physical status. User interactions with the game incorporate knee extension exercises and functional movements that provide optimal therapeutic benefits.
Participants in both groups will undergo combination of home and in clinic sessions. Protocol will start with six clinic visits in order to maximize familiarity with the exercise routines and equipment. Home sessions will be added after 2 weeks in rehabilitation. The sessions will consist of warm up, strengthening, balance, precision and gentle stretching exercises. Strengthening exercises will be focused on quadriceps, hamstring, calf and gluteal muscles. Stretching exercises will be focused on quadriceps, hamstring and calf muscles. Progression will be guided by the rehabilitation principles and participants response to the exercise. The amount of these exercises will depend on how they make the subject feel. The rehabilitation program will allow the subject to increase the amount of exercise they can perform. Exercises will be limited if the subject feels discomfort. Overall, protocol will consist of 36 sessions in total, 20 in clinic sessions and 16 home-based 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.
Overall, KneeBRIGHT has the potential to significantly enhance OA rehabilitation by improving functional recovery through physical practice of specific, adaptive exercise and promoting adherence through fun games and performance feedback. Use of the KneeBRIGHT system in teletherapy may increase access to remote/underserved areas and extend the range of existing rehabilitation facilities.
Statistical analysis Knee function assessed by composite KOOS score prior to the study 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 to produce a set of delta values. These delta values will be analyzed via Analysis of Covariance (ANCOVA). A p≤0.05 decision rule will be utilized as the rejection criterion.
Questionnaire results will be used to test the hypothesis that patients using the KneeBRIGHT system demonstrate increased levels of engagement compared to those conducting a conventional exercise routine. The questionnaire scores will be tallied to produce composite scores. These composite scores will be analyzed via a linear mixed model. A p≤0.05 decision rule will be used as the null hypothesis rejection criterion.
Timing data from the home visits will be analyzed by comparing the minutes of exercise with the KneeBRIGHT system to minutes of exercise with the standard exercise regimen in the control group to test the hypothesis that exercise duration is greater with the KneeBRIGHT system. Mean usage time on each system will be analyzed via Student's paired t-test, with P v≤0.05 as the null hypothesis rejection criterion.
- Conditions
- Osteo Arthritis Knee
- Being tested
- KneeBright Group, Standard Rehabilitation group
- Keywords
- knee osteoarthritis, video-game based interventions, strength, Precision
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KneeBright GroupOther
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.
Standard Rehabilitation groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| KneeBright group | Experimental | 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. Receives: Other: KneeBright Group |
| Standard Rehabilitation group | Active comparator | Participants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device. Receives: Other: Standard Rehabilitation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: KOOS scores will be measured at baseline, day 1 and at the end of intervention, at 12 weeks.
Secondary outcomes (1)
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.
Measured: Peak torque (muscle strength) will be measured at baseline, day 1 and at the end of intervention, at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jan 2020
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Barron Associates, Inc.
- Responsible party
- Principal investigator, Joseph Hart, University of Virginia
- Investigators
- Joseph M Hart, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187092
- Sponsor's protocol ID
- IRB-HSR# 21926
- Acronym
- KneeBRIGHT
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2019
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.
PubMed 25265612Adams RJ, Lichter MD, Ellington A, White M, Armstead K, Patrie JT, Diamond PT. Virtual Activities of Daily Living for Recovery of Upper Extremity Motor Function. IEEE Trans Neural Syst Rehabil Eng. 2018 Jan;26(1):252-260. doi: 10.1109/TNSRE.2017.2771272.
PubMed 29324411Adams RJ. Strength and BALance (SABAL) Virtual Trainer. NIA: 1R41AG046958-01A1, 2015.
Ardali G. A daily adjustable progressive resistance exercise protocol and functional training to increase quadriceps muscle strength and functional performance in an elderly homebound patient following a total knee arthroplasty. Physiother Theory Pract. 2014 May;30(4):287-97. doi: 10.3109/09593985.2013.868064. Epub 2014 Jan 7.
PubMed 24397371Babault N, Pousson M, Ballay Y, Van Hoecke J. Activation of human quadriceps femoris during isometric, concentric, and eccentric contractions. J Appl Physiol (1985). 2001 Dec;91(6):2628-34. doi: 10.1152/jappl.2001.91.6.2628.
PubMed 11717228Bell DR, Guskiewicz KM, Clark MA, Padua DA. Systematic review of the balance error scoring system. Sports Health. 2011 May;3(3):287-95. doi: 10.1177/1941738111403122.
PubMed 23016020Bennell K, Hinman R. Exercise as a treatment for osteoarthritis. Curr Opin Rheumatol. 2005 Sep;17(5):634-40. doi: 10.1097/01.bor.0000171214.49876.38.
PubMed 16093845Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.
PubMed 19817509Bossen D, Buskermolen M, Veenhof C, de Bakker D, Dekker J. Adherence to a web-based physical activity intervention for patients with knee and/or hip osteoarthritis: a mixed method study. J Med Internet Res. 2013 Oct 16;15(10):e223. doi: 10.2196/jmir.2742.
PubMed 24132044Bossen D, Veenhof C, Van Beek KE, Spreeuwenberg PM, Dekker J, De Bakker DH. Effectiveness of a web-based physical activity intervention in patients with knee and/or hip osteoarthritis: randomized controlled trial. J Med Internet Res. 2013 Nov 22;15(11):e257. doi: 10.2196/jmir.2662.
PubMed 24269911Cameron C. Patient compliance: recognition of factors involved and suggestions for promoting compliance with therapeutic regimens. J Adv Nurs. 1996 Aug;24(2):244-50. doi: 10.1046/j.1365-2648.1996.01993.x.
PubMed 8858426Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don't patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001 Feb;55(2):132-8. doi: 10.1136/jech.55.2.132.
PubMed 11154253Carr A. Barriers to the effectiveness of any intervention in OA. Best Pract Res Clin Rheumatol. 2001 Oct;15(4):645-56. doi: 10.1053/berh.2001.0179.
PubMed 11567545Chen H, Rong W, Ma X, Qu,Y and Xiong Z. An Extended Technology Acceptance Model for MobileSocial Gaming Service Popularity Analysis. Mobile Information Systems, vol. 2017. doi:10.1155/2017/3906953
Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.
PubMed 22588746
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") Phase II
- ClinicalTrials.gov ID
- NCT04187092
- Acronym / sponsor ID
- KneeBRIGHT / IRB-HSR# 21926
- Conditions
- Osteo Arthritis Knee
- Keywords
- knee osteoarthritis, video-game based interventions, strength, Precision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Barron Associates, Inc.
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoarthritis (OA) is the leading cause of disability in the United States. As osteoarthritis is associated with the lower limb muscle weakness, rehabilitation focused on quadriceps and other lower extremity muscle strengthening is a well-established treatment for patients with knee OA. However, patient adherence to exercise routines is low due to the lack of guidance regarding optimal protocols, and poor engagement during the repetitive routines that patients find tedious and boring.
Long-term goal of this study is to improve knee OA outcomes through effective and motivating rehabilitation exercises. The Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") system combines electromyography (EMG) biofeedback with video game therapy (VGT) 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.
Participants with age from 40-75, with independent ambulation and with the diagnosis of knee OA made by x-ray and a score of at least 2 (out of 4) on the Kellgren-Lawrence OA radiographic classification system will be included in the study. Participants with psychiatric or cognitive impairment (e.g., dementia), symptomatic spine, hip, ankle, or foot disease other than OA that would interfere with assessment of the knee will be excluded. Participants with balance or vestibular disorders, peripheral neuropathy, skin conditions that prevent EMG electrode placement, prisoner, pregnant women (by report), non-English-speaking, individuals who are visually and/or hearing impaired will also be excluded.
Eligible 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
Both groups will undergo same rehabilitation protocol which will begin with sessions supervised in the clinic by the study team physical therapist and gradually home sessions will be added. Participants in KneeBRIGHT group will perform the quadriceps strengthening exercises with the video-games based activities. The EMG biofeedback units and video game w/laptop will be provided to the subjects for home use. Subjects will receive instruction on how to apply the EMG biofeedback unit and use of the video game. KneeBRIGHT Game Activities consists of an introduction of the player to the virtual world and the missions, the player customizes the personal avatar and completes a series of calibration contractions and practice exercises to gain familiarity with the game controls. Through the EMG system, a player's muscle contractions translate into physical movements of the avatar and control of vehicles within the virtual environment. Each quest-type challenge is designed to permit play in a seated, supine, supported standing, or freestanding position, based on an individual's physical status. User interactions with the game incorporate knee extension exercises and functional movements that provide optimal therapeutic benefits.
Participants in both groups will undergo combination of home and in clinic sessions. Protocol will start with six clinic visits in order to maximize familiarity with the exercise routines and equipment. Home sessions will be added after 2 weeks in rehabilitation. The sessions will consist of warm up, strengthening, balance, precision and gentle stretching exercises. Strengthening exercises will be focused on quadriceps, hamstring, calf and gluteal muscles. Stretching exercises will be focused on quadriceps, hamstring and calf muscles. Progression will be guided by the rehabilitation principles and participants response to the exercise. The amount of these exercises will depend on how they make the subject feel. The rehabilitation program will allow the subject to increase the amount of exercise they can perform. Exercises will be limited if the subject feels discomfort. Overall, protocol will consist of 36 sessions in total, 20 in clinic sessions and 16 home-based 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.
Overall, KneeBRIGHT has the potential to significantly enhance OA rehabilitation by improving functional recovery through physical practice of specific, adaptive exercise and promoting adherence through fun games and performance feedback. Use of the KneeBRIGHT system in teletherapy may increase access to remote/underserved areas and extend the range of existing rehabilitation facilities.
Statistical analysis Knee function assessed by composite KOOS score prior to the study 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 to produce a set of delta values. These delta values will be analyzed via Analysis of Covariance (ANCOVA). A p≤0.05 decision rule will be utilized as the rejection criterion.
Questionnaire results will be used to test the hypothesis that patients using the KneeBRIGHT system demonstrate increased levels of engagement compared to those conducting a conventional exercise routine. The questionnaire scores will be tallied to produce composite scores. These composite scores will be analyzed via a linear mixed model. A p≤0.05 decision rule will be used as the null hypothesis rejection criterion.
Timing data from the home visits will be analyzed by comparing the minutes of exercise with the KneeBRIGHT system to minutes of exercise with the standard exercise regimen in the control group to test the hypothesis that exercise duration is greater with the KneeBRIGHT system. Mean usage time on each system will be analyzed via Student's paired t-test, with P v≤0.05 as the null hypothesis rejection criterion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| KneeBright group | Experimental | Other: KneeBright GroupParticipants 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. |
| Standard Rehabilitation group | Active comparator | Other: Standard Rehabilitation groupParticipants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-75
- Diagnosis of Osteoarthritis
- Independent ambulation without assistive device
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KneeBright GroupThe 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. | Other | KneeBright group |
| Standard Rehabilitation groupParticipants 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. | Other | Standard Rehabilitation group |
Primary outcome
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.
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.
1 secondary outcome
Change in Peak Torque of 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25265612Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.
- Background: PubMed 29324411Adams RJ, Lichter MD, Ellington A, White M, Armstead K, Patrie JT, Diamond PT. Virtual Activities of Daily Living for Recovery of Upper Extremity Motor Function. IEEE Trans Neural Syst Rehabil Eng. 2018 Jan;26(1):252-260. doi: 10.1109/TNSRE.2017.2771272.
- BackgroundAdams RJ. Strength and BALance (SABAL) Virtual Trainer. NIA: 1R41AG046958-01A1, 2015.
- Background: PubMed 24397371Ardali G. A daily adjustable progressive resistance exercise protocol and functional training to increase quadriceps muscle strength and functional performance in an elderly homebound patient following a total knee arthroplasty. Physiother Theory Pract. 2014 May;30(4):287-97. doi: 10.3109/09593985.2013.868064. Epub 2014 Jan 7.
- Background: PubMed 11717228Babault N, Pousson M, Ballay Y, Van Hoecke J. Activation of human quadriceps femoris during isometric, concentric, and eccentric contractions. J Appl Physiol (1985). 2001 Dec;91(6):2628-34. doi: 10.1152/jappl.2001.91.6.2628.
- Background: PubMed 23016020Bell DR, Guskiewicz KM, Clark MA, Padua DA. Systematic review of the balance error scoring system. Sports Health. 2011 May;3(3):287-95. doi: 10.1177/1941738111403122.
- Background: PubMed 16093845Bennell K, Hinman R. Exercise as a treatment for osteoarthritis. Curr Opin Rheumatol. 2005 Sep;17(5):634-40. doi: 10.1097/01.bor.0000171214.49876.38.
- Background: PubMed 19817509Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.
- Background: PubMed 24132044Bossen D, Buskermolen M, Veenhof C, de Bakker D, Dekker J. Adherence to a web-based physical activity intervention for patients with knee and/or hip osteoarthritis: a mixed method study. J Med Internet Res. 2013 Oct 16;15(10):e223. doi: 10.2196/jmir.2742.
- Background: PubMed 24269911Bossen D, Veenhof C, Van Beek KE, Spreeuwenberg PM, Dekker J, De Bakker DH. Effectiveness of a web-based physical activity intervention in patients with knee and/or hip osteoarthritis: randomized controlled trial. J Med Internet Res. 2013 Nov 22;15(11):e257. doi: 10.2196/jmir.2662.
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- Background: PubMed 11154253Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don't patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001 Feb;55(2):132-8. doi: 10.1136/jech.55.2.132.
- Brendon Hall groupLink provided by the sponsor.
- KOOS QuestionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M Hart, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KneeBright Group and Standard Rehabilitation group in people with Osteo Arthritis Knee, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187092, which also lists 75 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.