PT/OT + Caregiver Education for Infants with Cerebral Palsy

(CIRCLE-CP Trial)

JN
Overseen ByJasmine Ng, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers of infants with Cerebral Palsy (CP) or those at high risk for CP gain more knowledge, comfort, and confidence in supporting their children. Caregivers and their infants will attend a group "bootcamp" called Coaching, Learning, Empowerment in Cerebral Palsy Bootcamp. A team of health professionals, including physical and occupational therapists, will lead the sessions. The trial is ideal for caregivers of infants aged 3-15 months who are not yet walking independently and are medically stable. Participants must attend all sessions and speak English.

As an unphased trial, this study offers caregivers a unique opportunity to gain valuable skills and support in a collaborative environment.

What prior data suggests that this educational intervention is safe for caregivers and infants?

A previous study showed that specific exercises and a therapy called constraint-induced movement therapy (CIMT) improved movement in infants and toddlers with cerebral palsy (CP). This finding suggests that similar treatments might be helpful and safe. Early treatment for infants at high risk of CP is important and often recommended. These therapies enhance motor skills and are generally well-tolerated. No serious side effects have been reported, indicating safety for young children undergoing these therapies.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a holistic approach to managing cerebral palsy in infants by combining physical and occupational therapy (PT/OT) with caregiver education. Unlike traditional treatment options that primarily focus on direct therapy for the child, this approach empowers caregivers with the knowledge and skills needed to support their child's development at home. This could lead to more consistent support and potentially better developmental outcomes for the infant. By integrating caregiver involvement, the trial aims to create a more supportive environment that enhances the effectiveness of standard therapies.

What evidence suggests that this bootcamp is effective for infants with Cerebral Palsy?

This trial will evaluate the effectiveness of a structured program called Coaching, Learning, Empowerment in Cerebral Palsy Bootcamp, which emphasizes caregiver education and infant motor skills. Research has shown that coaching in motor skills can significantly benefit children with cerebral palsy, particularly those with higher functional abilities. Studies have found that this method also enhances caregivers' skills and confidence, enabling them to better support their children. Programs designed to empower caregivers can reduce feelings of being overwhelmed and isolated. Early intervention programs like this are promising because they focus on increasing caregiver knowledge and involvement. By involving caregivers in a structured program, these interventions aim to improve the overall quality of life for families with infants at risk for cerebral palsy.12678

Who Is on the Research Team?

JN

Jasmine Ng, MD

Principal Investigator

University of California San Frnacisco

Are You a Good Fit for This Trial?

Inclusion Criteria

* Infants 3-15 months corrected age at enrollment
* Diagnosed with CP or at high possibility of CP
* Not yet independently walking at baseline
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregivers participate in a 6-week integrated PT/OT caregiver 'Primer' bootcamp focusing on education and practical skills for early intervention in cerebral palsy.

6 weeks
Weekly group sessions

Follow-up

Participants are monitored for changes in caregiver knowledge, comfort, and confidence, as well as perceived benefits of the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Coaching, Learning, Empowerment in Cerebral Palsy Bootcamp

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Caregiver-InfantExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20576667/

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