NCT04997109 Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
| NCT ID | NCT04997109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 267 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 267 participants in total. It began in 2022-02-23 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.
Eligibility 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
Contact & Investigator
Nathalie Maitre, MD, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT04997109 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, up to 13 Months, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04997109 currently recruiting?
Yes, NCT04997109 is actively recruiting participants. Contact the research team at nathalie.linda.maitre@emory.edu for enrollment information.
Where is the NCT04997109 trial being conducted?
This trial is being conducted at Atlanta, United States, Baltimore, United States, Philadelphia, United States, Salt Lake City, United States.
Who is sponsoring the NCT04997109 clinical trial?
NCT04997109 is sponsored by Emory University. The principal investigator is Nathalie Maitre, MD, PhD at Emory University. The trial plans to enroll 267 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.