CompletedNo phase
Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
Key facts
- Who runs it
- Emory University
- Where
- Atlanta, Baltimore, Philadelphia, and Salt Lake City, United StatesSee the 4 sites
- Trial code
- Status
- Completed
- People taking part
- 269 people enrolled
- Started
- 23 Feb 2022
- Ended
- 12 Oct 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- APPLES-tele
- Parent-centered Approach (PCA) Support Intervention
- Standard of Care
- Record updated
- 4 November 2026
Who can take part
- Age
- 4 months to 13 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any prior long-term hard constraint programs
- Congenital malformation of the brain or musculoskeletal system (MSK)
- Receipt of botulinum toxin to the affected extremity within 3 months of study entry
Where in United States
- Emory UniversityAtlanta, United StatesNo longer taking part
- Kennedy Krieger InstituteBaltimore, United StatesNo longer taking part
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
- The University of UtahSalt Lake City, United StatesNo longer taking part
About the trial
What the trial wants to find out
This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.
The 3 groups in the trial
- APPLES-tele first, then PCATreatment being tested
Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks.
Treatment: APPLES-tele and Parent-centered Approach (PCA) Support Intervention
- PCA first, then APPLES-teleTreatment being tested
Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks.
Treatment: APPLES-tele and Parent-centered Approach (PCA) Support Intervention
- Standard of Care Control ArmExisting treatment, for comparison
Participants receiving the standard of care for 6 weeks.
Treatment: Standard of Care
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 November 2026