Augmented Reality Exercise for Cerebral Palsy

Overseen By Abigail Padilla, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Developmental delay, Hearing loss, Visual impairment, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a fun, augmented reality exercise program for children with cerebral palsy. The goal is to determine if an app guiding home exercises can improve physical activity and mobility. Children who can walk (with mild to moderate limitations) and speak English or Spanish may qualify. Participants will use the app on an iPad for short exercise sessions several times a week over a month. The study will track progress and gather feedback through surveys and interviews. As an unphased trial, this study offers a unique opportunity for children to engage with innovative technology that could enhance their mobility and physical activity.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this augmented reality exercise program is safe for children with cerebral palsy?

Research shows that augmented reality (AR) exercise games are generally well-received. Studies indicate that these games are easy to use and popular with children. For instance, one study found that children without developmental issues enjoyed playing AR games, suggesting they are safe and simple to use. Although these studies do not specifically focus on children with cerebral palsy, the positive feedback from other children is promising. No major reports of negative side effects have emerged from these studies, suggesting that the treatment is likely safe, though individual experiences may differ. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about augmented reality exergames for cerebral palsy because this approach combines physical exercise with interactive gaming, making therapy more engaging and accessible. Unlike traditional physical therapies that often need in-person sessions with therapists, this treatment can be accessed at home via an app, increasing convenience and potentially boosting adherence. The technology offers real-time data tracking and feedback, allowing for personalized adjustments and progress monitoring. This innovative method could revolutionize how therapy is delivered for cerebral palsy, making it more fun and flexible for patients.

What evidence suggests that Augmented Reality Exergames are effective for cerebral palsy?

Research shows that augmented reality (AR) exercise games can benefit children with cerebral palsy (CP). In this trial, participants will use the Augment Therapy™ mobile app, which has shown promise in previous studies. One study found that families of children with CP had positive experiences using the app, suggesting it could help increase physical activity. Another study found that virtual reality-based rehabilitation, which is similar, improved motor skills, aiding children with CP in moving better. Although AR exercise games have mostly been tested with children without CP, they have been found easy to use and enjoyable. Overall, AR exercise games could effectively encourage exercise and improve movement skills in children with CP. ^{1 3 6 7 8}

Who Is on the Research Team?

Melissa Bent, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking children with cerebral palsy who can walk (GMFCS I-II) and have no major surgeries planned for their legs in the next 4 months. It's not for kids with moderate to severe cognitive delays, significant hearing or vision problems, or recent surgeries/fractures affecting activity.

Inclusion Criteria

I have been diagnosed with cerebral palsy.

I can walk without assistance.

I do not plan to have leg surgery in the next 4 months.

Exclusion Criteria

I have a significant learning or developmental delay.

I have significant hearing or vision loss.

I had surgery or a bone break in the last 4 months affecting my movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or in-person)

Treatment

Participants engage in a home-based physical activity intervention using an AR app for 4 weeks

4 weeks

Weekly virtual check-ins

Follow-up

Participants complete final surveys and an exit interview to assess the intervention's impact

1-2 weeks

1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Augment Reality Exergames

Trial Overview The study tests if augmented reality exergames can increase physical activity over a 12-week period at home. Kids will be split into two groups randomly: one uses an AR app for exercises, while the other follows a traditional exercise program with handouts.

How Is the Trial Designed?

Group I: Augment Therapy app Experimental Treatment 1 Intervention

The app will be implemented with the participant's compatible iPad that will be securely integrated with a network-server for real-time data access and storage. If the participant does not have a compatible device, this will be provided by the research team. Participants will be provided an on-site or virtual CHLA tutorial about using the app and set up of the gaming system. Participants will access their home program on the app at least for 20 minutes, 3 times a week over a 4-week period. A coordinator will check in virtually with the participant during the program. They will complete baseline and final surveys. Exercise data will be collected and stored through the Augment Therapy™ app and self log book.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

The study tested three augmented reality (AR) systems for their ability to induce physiological responses similar to traditional exercise, finding that the Slap Stream and Drums games significantly increased heart rate and skin conductance, indicating effective engagement in physical activity.

Among the tested systems, Slap Stream was the most effective, achieving the highest rates of low, moderate, and high-intensity heart rates, demonstrating that affordable AR systems can enhance exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological Monitoring During Augmented Reality Exercise Confirms Advantages to Health and Well-Being. Wiederhold, MD., Crisci, M., Patel, V., et al.[2019]

The study involved 48 multi-ethnic teens aged 12 to 14, who provided valuable insights into their preferences for an Exergame that uses self-representational avatars, which may enhance physical activity during gameplay.

The research highlights the importance of understanding teen expectations and preferences in developing engaging Exergames, suggesting that personalized avatars could lead to increased intensity and duration of physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of A Teen-Focused Exergame. Thompson, D., Cantu, D., Rajendran, M., et al.[2022]

Active video games (AVGs) can significantly increase energy expenditure (EE) in nonambulatory wheelchair users, with participants showing up to a 30.8% increase in EE during Wii games.

The study demonstrated that AVGs can be adapted for individuals with varying levels of upper extremity limitations, making them a feasible method for promoting physical activity among those with severe disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using active video gaming as a means for increasing energy expenditure in three nonambulatory young adults with disabilities. Rowland, JL., Rimmer, JH.[2012]

In a pilot study involving 11 children with cerebral palsy, the group that underwent a 1-week virtual reality (VR) intervention followed by a 6-week home active video gaming (AVG) program did not show significant improvements in gross motor skills compared to the AVG-only group.

The AVG-only group showed a significant improvement in gross motor function, while the VR + AVG group experienced a notable decrease in walking distance, indicating that the combination of VR and AVG may not be beneficial and could even be counterproductive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Video Gaming for Children with Cerebral Palsy: Does a Clinic-Based Virtual Reality Component Offer an Additive Benefit? A Pilot Study. Levac, D., McCormick, A., Levin, MF., et al.[2018]

A case report involving an adolescent with spastic diplegic cerebral palsy showed that using a low-cost gaming system (Wii) for rehabilitation resulted in significant improvements in visual-perceptual processing, postural control, and functional mobility after 11 training sessions.

This study demonstrates the feasibility of integrating commercially available gaming technology into rehabilitation programs for individuals with cerebral palsy, suggesting a potential new avenue for enhancing traditional therapy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Deutsch, JE., Borbely, M., Filler, J., et al.[2022]

Augmented reality (AR) interventions significantly improved upper extremity function and balance in 30 children aged 6 to 12 years with spastic hemiplegic cerebral palsy after 8 weeks of gameplay.

Among the AR games tested, 'Balance It' showed the most promise in enhancing balance, although all games were effective and no significant differences were found in upper extremity function across the different games.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Augmented Reality Interventions on the Function of Upper Extremity and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial. Malick, WH., Butt, R., Awan, WA., et al.[2022]

Clinicians believe that cycling-based exergames can benefit children with cerebral palsy (CP) and may also be applicable to other pediatric populations, highlighting a positive perspective on their potential use in rehabilitation.

However, barriers such as limited clinician time and misalignment of exergame responsibilities with their roles could hinder the implementation of these interventions in inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician perspectives on the implementation of inpatient cycling-based exergames for children with cerebral palsy: A qualitative study. Cardenas, A., Petrevska, M., Biddiss, E., et al.[2022]

The study involving 15 children with spastic cerebral palsy found that computer-assisted arm rehabilitation gaming did not lead to significant improvements in arm function compared to usual treatment, as measured by the ABILHAND-kids scores.

Although there was a statistically significant improvement in the Canadian Occupational Performance Measure scores over time, it did not reach the minimal clinically important difference, suggesting that the gaming intervention may not be effective enough to produce meaningful functional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy. Preston, N., Weightman, A., Gallagher, J., et al.[2021]

Many children and adolescents in Canada, the UK, and the USA are not meeting their recommended levels of physical activity, which increases their risk of obesity and related health issues.

GPS-enabled exergames, which encourage outdoor physical activity, show promise in increasing activity levels among young people, but further research is needed to evaluate their health benefits and improve public adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exergames for health and fitness: the roles of GPS and geosocial apps. Boulos, MN., Yang, SP.[2021]

In a study involving 20 children and adolescents with cerebral palsy, wrist-worn accelerometers provided significantly higher and more accurate measurements of exercise intensity during active video games compared to hip-worn accelerometers.

The wrist-worn accelerometers recorded metabolic equivalents (METs) exceeding the moderate intensity threshold (3 METs), while hip-worn devices tended to underestimate exercise intensity, indicating that wrist placement may be more effective for monitoring physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise intensity of active video gaming in cerebral palsy: hip- versus wrist-worn accelerometer data. Kaya Ciddi, P., Yilmaz, Ö.[2022]

An 8-week augmented reality (AR) exercise program significantly improved muscle strength, endurance, balance, and flexibility in 27 individuals with developmental disabilities, indicating its efficacy as a rehabilitation method.

The AR-based dual-task program particularly increased interest and motivation in participants with higher cognitive abilities, suggesting that cognitive level may influence the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Augmented Reality-Based Dual-Task Program on Physical Ability by Cognitive Stage with Developmental Disabilities. Kang, HY., Lee, DY., Hong, JH., et al.[2023]

Augmented reality (AR) interventions significantly improved the range of motion (ROM) and muscle strength in the upper extremities of 30 children aged 6 to 12 with spastic hemiplegic cerebral palsy after 8 weeks of treatment.

Among the different AR games used, the 'Balance It' game led to the most notable improvement in elbow extension ROM compared to the 'Scoop'd' game, although there were no significant differences in muscle strength across the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Augmented Reality Intervention on the Range of Motion and Muscle Strength of Upper Extremity in Children with Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial. Malick, WH., Butt, R., Awan, WA., et al.[2022]

The study found that 87.5% of the 48 recruited teens completed all activities, indicating that using a photorealistic avatar in exergames is feasible and enjoyable, with high scores in game enjoyment and satisfaction.

During gameplay, teens engaged in vigorous physical activity for about 15.88 minutes, which accounted for 74.9% of the total gameplay time, suggesting that this type of exergame can effectively increase physical activity levels among youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photorealistic Avatar and Teen Physical Activity: Feasibility and Preliminary Efficacy. Thompson, DI., Cantu, D., Callender, C., et al.[2023]

Kinect exergames for the Xbox 360 have potential benefits for various age groups, including improvements in physical, mental, and emotional health, but more research is needed to fully understand their effectiveness.

Current studies on digital exergames are abundant, but there is a lack of specific research on Kinect exergames, particularly regarding their role in obesity management and cognitive improvement in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Xbox 360 Kinect Exergames for Health. Kamel Boulos, MN.[2022]

Citations

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Augmented Reality Exergames for Upcoming Cognitive-Motor ... This study demonstrates that our exergame, comprising two AR games, is user-friendly and well-received by typically developing children, eliciting positive ...

2. mdpi.com mdpi.com/2077-0383/12/22/7091

Application of Virtual Reality-Assisted Exergaming on the ... The 2020 retrospective cohort study conducted at Samsung Changwon Hospital, investigating the effects of virtual reality-based rehabilitation on upper extremity ...

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Efficacy analysis of psychomotor impairment using virtual ... The present study aimed to evaluate the efficacy of VR-based exergames in improving motor and perceptual functions by analyzing performance scores and task ...

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31 A clinical trial using exergaming with augmented reality ... DISCUSSION/SIGNIFICANCE: Families of children with CP reported positive experiences overall with Augment Therapy™ mobile app. The technical issues will need to ...

5. newswise.com newswise.com/articles/can-augmented-reality-improve-exercise-for-children-with-cerebral-palsy

Can Augmented Reality Improve Exercise for Children With ... Exercise plays a key role in helping children with cerebral palsy to improve or maintain their mobility, including the ability to walk.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06944613

Augmented Reality Training for Cerebral Palsy ... The investigators have developed an exergame, using an augmented reality (AR) headset, which will eventually offer a new form of rehabilitation, ...

7. dl.acm.org dl.acm.org/doi/10.1145/2910017.2910612

Augmented reality-based exergames for rehabilitation This paper presents an augmented reality based system for rehabilitation by playing four interactive, cognitive and fun Exergames (exercise and gaming).

8. researchgate.net researchgate.net/publication/388125879_Augmented_reality_exergames_for_upcoming_cognitive-motor_rehabilitation_Insights_from_the_user_experience_of_healthy_children_Preprint

Augmented reality exergames for upcoming cognitive- ... Conclusions This study demonstrates that our exergame, comprising two AR games, is user-friendly and well-received by typically developing ...