Telemedicine approach for treating cerebral palsy in infants
Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
This study tests if telemedicine can help improve arm movement in infants with cerebral palsy by using two different treatments compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 267 (estimated) |
| Ages | 4 Months to 13 Months |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT04997109 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two active treatments and a standard care group for infants diagnosed with cerebral palsy. It focuses on improving upper extremity function through constraint-induced movement therapy and bimanual therapy, delivered in a telemedicine format. The interventions are designed to be adaptable for various settings, ensuring that they incorporate best clinical practices while being accessible to families. The study aims to provide evidence-based strategies that can be implemented in resource-limited environments.
Who should consider this trial
Good fit: Ideal candidates are infants aged 4 to 13 months with a diagnosis of cerebral palsy or a high risk of developing it.
Not a fit: Patients with congenital brain or musculoskeletal malformations or those who have received botulinum toxin treatment within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor function and quality of life for infants with cerebral palsy.
How similar studies have performed: Other studies have shown promise in using telemedicine for pediatric therapies, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 4 to 13 months, corrected age * Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (\>95% risk of later CP) * Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement * Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands \>1 * Parent/legal guardian is able to provide informed consent Exclusion Criteria: * Congenital malformation of the brain or musculoskeletal system (MSK) * Receipt of botulinum toxin to the affected extremity within 3 months of study entry * Any prior long-term hard constraint programs
Where this trial is running
Atlanta, Georgia and 3 other locations
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Kennedy Krieger Institute — Baltimore, Maryland, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- The University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Nathalie Maitre, MD, PhD — Emory University
- Study coordinator: Nathalie Maitre, MD, PhD
- Email: nathalie.linda.maitre@emory.edu
- Phone: (678) 476-5332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.