Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04997109
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
4 Months - 13 Months
Healthy Volunteers
Not accepted

Interventions

  • APPLES-tele — OTHER
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Feb 23, 2022
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
267 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

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.

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) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Nathalie Maitre, MD, PhD
[email protected]
(678) 476-5332
Nathalie Maitre, MD, PhD (PRINCIPAL_INVESTIGATOR)
Kennedy Krieger InstituteBaltimoreMaryland21205
Vera Joanna Burton, MD, PhD
[email protected]
Vera Joanna Burton, MD, PhD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Andrea F Duncan, MD, MS
[email protected]
Andrea F Duncan, MD, MS (PRINCIPAL_INVESTIGATOR)
The University of UtahSalt Lake CityUtah84112
Betsy Ostrander, MD
[email protected]
Betsy Ostrander, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University· Atlanta, GAKennedy Krieger Institute· Baltimore, MDChildren's Hospital of Philadelphia· Philadelphia, PAThe University of Utah· Salt Lake City, UT

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