Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Maryland
Kennedy Krieger Institute
RECRUITING
Baltimore
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Utah
The University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Nathalie Maitre, MD, PhD
nathalie.linda.maitre@emory.edu
(678) 476-5332
Time Frame
Start Date: 2022-02-23
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 267
Treatments
Experimental: APPLES-tele first, then PCA
Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks.
Experimental: PCA first, then APPLES-tele
Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks.
Active_comparator: Standard of Care Control Arm
Participants receiving the standard of care for 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: Emory University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov