Virtual Intervention for Infants with Cerebral Palsy

(RECOVER Trial)

Overseen By Rosanna Yankanah, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Genetic syndrome, Non-biological parents, English fluency, No internet, 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: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new virtual care model to assist infants with cerebral palsy, a brain injury. Researchers aim to determine if online therapy can enhance brain development in infants compared to traditional in-person care. They also seek to understand the influence of parents and social factors on outcomes and examine the cost benefits of a virtual clinic. Infants who experienced a brain injury at birth and exhibit specific movement issues may qualify for this trial. As an unphased study, this trial provides a unique opportunity for families to contribute to innovative research that could shape future care models for infants with cerebral palsy.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this virtual care model is safe for infants with cerebral palsy?

Research has shown that virtual care is generally safe and beneficial for children with cerebral palsy (CP). Telehealth, a type of virtual care, has shown promise in helping these children improve their abilities and makes healthcare services more accessible for families.

Studies have also supported using virtual care to assess the health needs of people with intellectual disabilities, indicating that virtual care can be a valuable tool for providing necessary healthcare. Additionally, telemedicine, which provides healthcare services remotely, has assisted families transitioning from hospital to home care for children with CP.

Overall, evidence suggests that virtual care is well-received and can safely assist children with CP and their families in managing health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual care for infants with cerebral palsy because it offers a unique way to deliver therapy directly to families at home, making it more accessible and convenient. Unlike traditional therapies that require frequent visits to clinics or hospitals, virtual care can be tailored to fit into daily routines, reducing the burden on families. Additionally, this approach allows for real-time feedback and adjustments, potentially leading to more personalized and effective interventions for each child.

What evidence suggests that virtual care is effective for infants with cerebral palsy?

Research has shown that virtual care, which participants in this trial may receive, can benefit children with cerebral palsy. Studies have found that telehealth, a type of virtual care, not only improves children's functioning but also makes healthcare more accessible. For instance, a personalized telehealth program helped children with cerebral palsy achieve their goals more effectively. Additionally, virtual reality, another form of virtual care, has successfully improved movement, balance, and posture. These findings suggest that virtual care can support better brain development outcomes for infants with cerebral palsy. ^{1 6 7 8 9}

Who Is on the Research Team?

Linh Ly, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for infants with brain injuries related to oxygen deprivation at birth, specifically those who have had abnormal movements by 12 weeks old, were born after 34 weeks of pregnancy, received cooling therapy, are followed by the Neonatal Follow-Up Clinic at SickKids, and have an abnormal brain MRI. Infants must also be diagnosed with moderate to severe hypoxic ischemic encephalopathy. Those with genetic syndromes, not living with biological parents post-discharge, limited English fluency or no internet can't participate.

Inclusion Criteria

I have undergone therapeutic hypothermia treatment.

Your baby does not show normal movements by 12 weeks old.

You are at least 34 weeks pregnant.

Exclusion Criteria

I am not fluent in English.

I have or am suspected to have a genetic syndrome.

No internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual early intervention care to enhance neurodevelopmental outcomes

5 years

Regular virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Care

Trial Overview

The study tests a virtual care model over five years to see if it improves development in infants with brain injury from lack of oxygen at birth. It's a randomized controlled trial comparing usual care against this new virtual intervention method while examining parental impact and cost-effectiveness.

How Is the Trial Designed?

Group I: Virtual Care Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Virtual Care is already approved in Canada for the following indications:

Approved in Canada as Virtual Care for:

• Acute Kidney Injury (AKI)
• Reducing hospital readmission rates
• Improving long-term outcomes

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

A pilot study involving 9 children with cerebral palsy demonstrated that individualized, supervised home-based training delivered via the internet can effectively maintain intensive training over 20 weeks, leading to significant improvements in motor strength and cognitive abilities.

Participants reported high satisfaction with the training, and on average, they engaged in over 74 hours of training, resulting in enhanced functional muscle strength and visual perceptual skills, indicating that this method can be a viable alternative to traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized, home-based interactive training of cerebral palsy children delivered through the Internet. Bilde, PE., Kliim-Due, M., Rasmussen, B., et al.[2021]

The study found no significant differences in enrollment or referral rates to therapies between infants assessed via virtual visits and those assessed in person, indicating that virtual assessments can be as effective as in-person ones.

Infants who had their first developmental assessment virtually were just as likely to complete all follow-up assessments, suggesting that virtual visits do not compromise follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Visits for Developmental Screening in High-Risk Infants. Jayaraman, M., Gupta, M., Varghese, N., et al.[2023]

A telehealth intervention for infants with asymmetric cerebral palsy showed promising results, with a significant improvement in fine motor functioning of the more affected upper extremity, indicated by a large effect size (Cohen d = 0.92) after treatment.

The intervention demonstrated high treatment fidelity among parents, with an average adherence rate of 95.7%, suggesting that the telehealth model is feasible for delivering this type of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol and Feasibility-Randomized Trial of Telehealth Delivery for a Multicomponent Upper Extremity Intervention in Infants With Asymmetric Cerebral Palsy. Pietruszewski, L., Burkhardt, S., Yoder, PJ., et al.[2022]

A study involving 34 children with cerebral palsy showed that individualized, supervised home-based training delivered via the internet significantly improved daily activities and upper and lower limb functions after 20 weeks of training.

The children in the training group completed an average of 17 minutes of daily exercises, leading to measurable functional improvements, while the control group showed no changes, highlighting the effectiveness of this training approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty weeks of home-based interactive training of children with cerebral palsy improves functional abilities. Lorentzen, J., Greve, LZ., Kliim-Due, M., et al.[2018]

Citations

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frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1582110/full

Effectiveness of virtual reality for functional disorders in ...

Eligible studies were required to (1) have participants who were diagnosed with cerebral palsy and were aged ≤18 years; (2) compare VR ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6692882/

Effectiveness of Virtual Reality in Children With Cerebral Palsy

Researchers recently investigated the effectiveness of virtual reality (VR) in helping children with cerebral palsy (CP) to improve motor function.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2215016124004515

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11626090/

Using Virtual Care to Assess the Health Needs of People With ...

Evidence exists to support the use of virtual care for screening, diagnosis, assessment, and review of people with intellectual disabilities.

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npjournal.org

npjournal.org/article/S1555-4155(24)00361-1/abstract

Telemedicine Visits After Hospital Discharge in Children ...

Parental caregivers' perception of their transition from hospital to home in children with cerebral palsy who have undergone orthopedic surgery.

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sciencedirect.com

sciencedirect.com/science/article/pii/S0891524524000257

Healthcare Interventions for Children Using Nonimmersive ...

Effects of nonimmersive virtual reality intervention on children with spastic cerebral palsy: A meta-analysis and systematic review. American Journal of ...

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researchgate.net

researchgate.net/publication/391967270_Telemedicine_for_Children_With_Cerebral_Palsy_Before_During_and_After_the_COVID-19_Pandemic_An_Australian_Cohort_Study

Telemedicine for Children With Cerebral Palsy Before, ...

Main outcomes: Reductions in care defined by predicted hospital contact rates for 2020, estimated from 2015 to 2019, minus observed rates per 1000 child ...