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

Trial Summary

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 data supports the effectiveness of the treatment Knee Biofeedback Rehabilitation, KneeBRIGHT, Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy for osteoarthritis?

Research shows that using video games with biofeedback can help improve movement quality and engagement in therapy, as seen in studies with patients with cerebral palsy and musculoskeletal conditions. This suggests that similar game-based biofeedback systems like KneeBRIGHT could be effective for knee osteoarthritis by encouraging better exercise habits and muscle strength. ^{1 2 3 4 5}

Is game therapy for osteoarthritis safe for humans?

The studies on game-based therapies for knee osteoarthritis, like KneeBright and similar systems, suggest they are generally safe for humans, as they focus on exercises and biofeedback to improve muscle strength without reported safety issues. ^{1 5 6 7 8}

How is the Knee Biofeedback Rehabilitation treatment different from other treatments for knee osteoarthritis?

Knee Biofeedback Rehabilitation (KneeBRIGHT) is unique because it uses a video game system that incorporates electromyography (EMG) biofeedback to help patients strengthen their quadriceps muscles at home. This approach not only makes the therapy more engaging but also provides real-time feedback to improve exercise quality, which can enhance patient compliance and motivation compared to traditional exercise methods. ^{1 2 5 7 9}

What is the purpose of this trial?

The goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis. The main question the study aims to answer is: do patients who exercise with the game have better functional outcomes and engagement compared to patients who do conventional exercise? Participants will complete 10 weeks of physical therapy exercise sessions that focus on quadriceps strengthening. Two sessions per week will be conducted in the clinic, and one session will be conducted at home each week. The interventional group will conduct all exercises using the KneeBRIGHT EMG sensors and game software. The control group will conduct all exercises following a standard physical therapy regimen. Researchers will compare knee function and engagement between the group who uses the game, and the group who does conventional exercise.

Research Team

Eileen Krepkovich, MS

Principal Investigator

Barron Associates

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Novel Video Game-Based Electromyography Biofeedback System in Patients With Knee Osteoarthritis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The design and evaluation of electromyography and inertial biofeedback in hand motor therapy gaming. [2022]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Serious Gaming to Support Exercise Therapy for Patients with Chronic Nonspecific Low Back Pain: A Feasibility Study. [2018]

5. Poland pubmed.ncbi.nlm.nih.gov

Early Rehabilitation with Exergame - Which Muscle Groups are Addressed by Bedside-Based Knee Exercises? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I design and evaluation of an isometric muscle reeducation device for knee osteoarthritis rehabilitation. [2019]

7. United States 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. [2014]

8. England 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Design and evaluation of an exergame system to assist knee disorders patients' rehabilitation based on gesture interaction. [2023]