Game Therapy for Osteoarthritis

(KneeBRIGHT Trial)

Overseen By Eileen Krepkovich, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barron Associates, Inc.

Disqualifiers: Psychiatric, Cognitive impairment, Spine disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

Duration: 10 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether video games for physical therapy can improve knee function and engagement in people with knee osteoarthritis. Participants will split into two groups: one will use the KneeBRIGHT game (part of the Knee Biofeedback Rehabilitation therapy) with sensors for exercises, while the other will follow regular physical therapy routines. The researchers aim to determine if the game-based approach leads to better outcomes. Individuals diagnosed with knee osteoarthritis who can walk without support might be a good fit. As an unphased trial, this study offers a unique opportunity to explore innovative therapy methods that could enhance the rehabilitation experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this game therapy is safe for knee osteoarthritis patients?

Research shows that the KneeBRIGHT system, which uses biofeedback and video games for rehabilitation, is generally well-received by people with knee osteoarthritis. Studies have found that patients using this system participate more in their exercises and build stronger knees compared to traditional methods. Importantly, these studies reported no major side effects, suggesting that the treatment is safe for participants. Overall, KneeBRIGHT appears to be a promising and safe option for those seeking to improve knee function through fun and effective exercise routines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about game therapy for osteoarthritis because it introduces an innovative and interactive approach to rehabilitation. Unlike traditional physical therapy, which relies on standard exercises, this method uses KneeBRIGHT electromyogram sensors and game software to provide real-time feedback and make exercises more engaging. By transforming rehabilitation into a game-like experience, it aims to increase patient motivation and adherence, potentially leading to better outcomes. Plus, the use of biofeedback technology helps patients fine-tune their movements, which could enhance the effectiveness of their therapy sessions.

What evidence suggests that the Knee Biofeedback Rehabilitation is effective for knee osteoarthritis?

Research has shown that Knee Biofeedback Rehabilitation, such as the KneeBRIGHT system, can improve knee osteoarthritis. In this trial, participants in the KneeBRIGHT Group will use the KneeBRIGHT electromyogram sensors and game software during their 10-week therapy regimen. Studies indicate that video-game-based exercises motivate patients to continue their therapy. This method enhances physical recovery by making regular exercise more engaging through fun games. Patients who used biofeedback, which provides real-time body signals, reported better recovery than those performing traditional exercises. Early results suggest that KneeBRIGHT may lead to improved knee function and increased patient participation. ^{1 2 3 6 7}

Who Is on the Research Team?

Eileen Krepkovich, MS

Principal Investigator

Barron Associates

Are You a Good Fit for This Trial?

This trial is for adults with knee osteoarthritis confirmed by x-ray, who can walk on their own without help. They should have a moderate level of disease severity and be able to follow instructions. People with mental impairments or other lower body joint issues that could affect knee assessment cannot join.

Inclusion Criteria

Diagnosis via x-ray, with a score of at least 2 (out of 4) on the Kellgren-Lawrence OA scoring system

I can walk on my own without any help or devices.

Exclusion Criteria

Individuals who have psychiatric or cognitive impairment (e.g., dementia) that interferes with their ability to follow instructions or provide voluntary consent

I do not have painful conditions in my spine, hip, ankle, or foot that would affect knee pain assessment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 10 weeks of physical therapy exercise sessions focusing on quadriceps strengthening, with two sessions per week in the clinic and one session at home.

10 weeks

20 visits (in-person), 10 sessions (home-based)

Follow-up

Participants are monitored for functional outcomes and engagement after completing the exercise regimen.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Knee Biofeedback Rehabilitation

Trial Overview The study tests if a video-game based exercise program (KneeBRIGHT System) leads to better function and more engagement in therapy compared to standard exercises for knee osteoarthritis over 10 weeks, including sessions both at home and in the clinic.

How Is the Trial Designed?

Group I: KneeBRIGHT Group Experimental Treatment 1 Intervention

The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software.

Group II: Control Group Active Control 1 Intervention

The control group will conduct all exercises following a standard physical therapy regimen.

Knee Biofeedback Rehabilitation is already approved in United States for the following indications:

Approved in United States as KneeBRIGHT for:

• Knee osteoarthritis rehabilitation

Who Is Running the Clinical Trial?

Barron Associates, Inc.

Lead Sponsor

Trials

11

Recruited

520+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

In a study involving 20 individuals with knee osteoarthritis, real-time biofeedback significantly reduced performance error in toe-out gait modification compared to mirror and raw video feedback methods, with a mean difference of 2.05° and 1.51°, respectively.

Despite the improvement in performance error with real-time biofeedback, participants did not perceive a significant difference in difficulty across the feedback methods, suggesting that the benefits of real-time biofeedback may not justify its higher costs in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mirror, raw video, and real-time visual biofeedback for training toe-out gait in individuals with knee osteoarthritis. Hunt, MA., Takacs, J., Hart, K., et al.[2014]

Knee exercises performed in a seated position with a 45-degree trunk inclination resulted in the highest muscle activation, making it the most effective position for rehabilitation exercises.

Elevating the knee by 30mm during exercises significantly increased activation of the ischiocrural muscles, suggesting that slight adjustments in positioning can enhance the effectiveness of knee rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Rehabilitation with Exergame - Which Muscle Groups are Addressed by Bedside-Based Knee Exercises? Horstmann, H., Krost, E., Weber-Spickschen, TS.[2023]

A 12-week randomized controlled trial with 38 older adults showed that a computer-aided rowing exercise (CRE) program significantly improved muscle strength and functional fitness in those with mild knee osteoarthritis compared to a conventional exercise program.

Participants in the CRE group had notable enhancements in various strength measures (e.g., hip and knee muscles) and overall health conditions, indicating that technology-supported exercise can be more effective for managing knee OA in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of computer-aided rowing exercise systems on improving muscle strength and function in older adults with mild knee osteoarthritis: a randomized controlled clinical trial. Lin, PL., Yu, LF., Kuo, SF., et al.[2022]

The KneeBright virtual game system significantly improved knee extension torque by an average of 25% compared to a conventional electromyography biofeedback system in patients with knee osteoarthritis, indicating enhanced efficacy in strength training.

Patients reported high levels of engagement and usability with the KneeBright system, scoring 3.4/5 on the technology acceptance model and 79 on the System Usability Score, suggesting it is a user-friendly and effective rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Novel Video Game-Based Electromyography Biofeedback System in Patients With Knee Osteoarthritis. Krepkovich, E., Kaur, M., Mangum, LC., et al.[2022]

A knee rehabilitation exercise game (Exergame) was developed for home-based rehabilitation of patients with knee disorders, showing a high motion recognition accuracy of 95.2%, which indicates its effectiveness in guiding rehabilitation for knee osteoarthritis (KOA) patients.

User experience evaluations from 20 KOA patients revealed excellent satisfaction with the system, suggesting it enhances patient compliance and willingness to engage in active rehabilitation exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of an exergame system to assist knee disorders patients' rehabilitation based on gesture interaction. Wang, G., Zhu, B., Fan, Y., et al.[2023]

The Isopad device, designed for a home-based isometric rehabilitation program, showed promise in helping five patients with knee osteoarthritis adhere to an 8-week supervised training, resulting in an average 30% increase in quadriceps and hamstring strength.

Patients reported improvements in functional complaints related to their knee osteoarthritis, as measured by the WOMAC index, indicating potential benefits of the Isopad program for managing symptoms of OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I design and evaluation of an isometric muscle reeducation device for knee osteoarthritis rehabilitation. Goldman, RJ., Reinbold, KA., Iglarsh, ZA., et al.[2019]

The study involving 16 older patients showed that combining physiotherapy with active video games (AVG) like Ring Fit Adventure is safe and feasible for rehabilitation, with no adverse events reported.

Participants expressed high levels of enjoyment and motivation to continue with the AVG training, indicating that this approach could enhance the rehabilitation experience for older adults with musculoskeletal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, feasibility, and acceptability of physiotherapy combined with strength training using active video games for older patients with musculoskeletal conditions. Takei, K., Morita, S., Watanabe, Y., et al.[2022]

A functional exercise program supported by serious gaming was found to be feasible for 10 patients with chronic nonspecific low back pain over 18 weeks, with no serious adverse events reported and high treatment satisfaction.

Participants felt that the serious games improved their exercise performance and confidence, although challenges such as time needed for game setup and the desire for postural feedback in daily activities were identified for future improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Gaming to Support Exercise Therapy for Patients with Chronic Nonspecific Low Back Pain: A Feasibility Study. Matheve, T., Claes, G., Olivieri, E., et al.[2018]

A biofeedback therapy game designed for young people with Cerebral Palsy showed significant improvements, with participants reducing compensatory arm movements by 10.2% and enhancing the quality of their gestures over a 4-week period.

The game was not only effective but also engaging, as participants enjoyed using it and frequently chose to review their biofeedback, highlighting the importance of user experience in therapy game design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The design and evaluation of electromyography and inertial biofeedback in hand motor therapy gaming. MacIntosh, A., Vignais, N., Vigneron, V., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04187092

Knee Biofeedback Rehabilitation Interface for Game-based ... Long-term goal of this study is to improve knee OA outcomes through effective and motivating rehabilitation exercises. The Knee Biofeedback Rehabilitation ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06090097

Knee Biofeedback Rehabilitation Through Game Therapy ... The goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9555188/

Feasibility of a Novel Video Game-Based Electromyography ... The study aimed to compare the KneeBright and electromyography biofeedback interface among patients with knee osteoarthritis.

4. reporter.nih.gov reporter.nih.gov/search/PWga62gbKEuArQSezI9_2A/project-details/10754273

Knee-Biofeedback Rehabilitation Interface for Game-based ... KneeBRIGHT will enhance rehabilitation by: (1) increasing functional recovery through physical practice of evidence-based exercise routines; (2) promoting ...

5. ctv.veeva.com ctv.veeva.com/study/knee-biofeedback-rehabilitation-interface-for-game-based-home-therapy-for-patients-with-knee-osteoar

Knee Biofeedback Rehabilitation Interface for Game-based Home ... KneeBRIGHT aims to motivate patients with knee OA to conduct regular muscle strengthening exercise through an engaging, EMG-driven video game therapy. Overall ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35690390/

Feasibility of a Novel Video Game-Based Electromyography ... Conclusions: Patients using the KneeBright game produced greater knee torque than patients using the conventional system, had positive levels of ...

7. barron-associates.com barron-associates.com/about/projects/kneebright/

KneeBRIGHT: Knee Biofeedback Rehabilitation Game for ... KneeBRIGHT combines electromyography biofeedback with video game therapy in a unique virtual rehabilitation system for osteoarthritis patients.