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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.

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 data supports the effectiveness of the treatment Virtual Care, Telemedicine, Remote Monitoring, Virtual Home Hospital for infants with cerebral palsy?

Research shows that home-based tele-assisted rehabilitation and telerehabilitation programs can significantly improve motor function, activity, participation, and goal achievement in children with cerebral palsy. These programs allow for effective remote interaction and guidance from clinicians, leading to improvements in movement, strength, and balance. ^{1 2 3 4 5}

Is virtual intervention for infants with cerebral palsy safe?

Research on virtual care, including telemedicine and remote monitoring, shows it is generally safe for infants and children. Studies have found that virtual visits and home-based interventions are feasible, well-received by families, and do not lead to increased risks or loss of follow-up. ^{6 7 8 9 10}

How is the Virtual Care treatment for infants with cerebral palsy different from other treatments?

Virtual Care for infants with cerebral palsy is unique because it uses telemedicine to provide personalized, home-based therapy that is remotely managed by clinicians. This approach allows for continuous, intensive training at home, which can be more convenient and accessible than traditional in-person therapy sessions. ^{1 3 7 8 11}

Research Team

Linh Ly, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

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

Home-based tele-assisted robotic rehabilitation of joint impairments in children with cerebral palsy. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Telerehabilitation-Based Structured Home Program on Activity, Participation and Goal Achievement in Preschool Children with Cerebral Palsy: A Triple-Blinded Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Twenty weeks of home-based interactive training of children with cerebral palsy improves functional abilities. [2018]

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

Remote Presence Robotic Technology Reduces Need for Pediatric Interfacility Transportation from an Isolated Northern Community. [2019]

5. Argentina pubmed.ncbi.nlm.nih.gov

Teleconsultation during a pandemic. Experience of developmental pediatricians at Hospital de Pediatría "Prof. Dr. Juan P. Garrahan". [2021]

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

Virtual Visits for Developmental Screening in High-Risk Infants. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Individualized, home-based interactive training of cerebral palsy children delivered through the Internet. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility Analysis of CareToy-Revised Early Intervention in Infants at High Risk for Cerebral Palsy. [2021]

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

A web-based communication system for integrated care in cerebral palsy: design features, technical feasibility and usability. [2015]

10. Norway pubmed.ncbi.nlm.nih.gov

Using telemedicine in the care of newborn infants after discharge from a neonatal intensive care unit reduced the need of hospital visits. [2022]

11. United States 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. [2022]