Recruiting

Active Treatments

Sponsor:

Emory University

Code:

NCT04997109

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

APPLES-tele

Parent-centered Approach (PCA) Support Intervention

Standard of Care

Study Details

Brief summary:

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

Conditions

Cerebral Palsy

Study ID

NCT04997109

Start date

Feb 23, 2022

Status verified date

Oct, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

267 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

APPLES-tele

The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty.

Parent-centered Approach (PCA) Support Intervention

The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.

Standard of Care

Participants will receive the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network.

Primary outcome measure

  • Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score [ Time Frame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention) ]
  • Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score [ Time Frame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention) ]

Central Contacts and Locations

Central contacts

Nathalie Maitre, MD, PhD

(678) 476-5332nathalie.linda.maitre@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nathalie Maitre, MD, PhD

(678) 476-5332Nathalie.linda.maitre@emory.edu

Principal Investigator:

Nathalie Maitre, MD, PhD

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Vera Joanna Burton, MD, PhD

BurtonJ@kennedykrieger.org

Principal Investigator:

Vera Joanna Burton, MD, PhD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Andrea F Duncan, MD, MS

duncana@chop.edu

Principal Investigator:

Andrea F Duncan, MD, MS

The University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Betsy Ostrander, MD

Betsy.ostrander@hsc.utah.edu

Principal Investigator:

Betsy Ostrander, MD

More Information

Sponsor

Emory University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-14.