Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

NCT04997109 | Recruiting DMC

• 2 other identifiers: STUDY000031972R01HD081120
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score

  The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function of the more affected upper extremity is assessed using the 54 unimanual items of the Bayley-3 instrument. Responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total unimanual fine motor raw scores for the more affected arm range from 0 to 108 where higher scores indicate greater fine motor function.

  Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

• Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score

  The Authoritative Parenting Style scale of the Parenting Styles and Dimensions Questionnaire (PSDQ) - short version, includes 15 items that are rated on a 5-point scale where 1 = never and 5 = always. The raw score ranges from 15 to 75 and higher scores indicate a more expression of the authoritative parenting style.

  Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

Secondary Outcomes (5)

• Change in Infant Motor Activity Log (IMAL) How Often Score

  Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

• Change in Hand Assessment in Infants (HAI) Score

  Baseline, Week 6 (after the first intervention)

• Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score

  Baseline, Week 6 (after the first intervention)

• Change in Welch Emotional Connection Screen (WECS) Score

  Baseline, Week 6 (after the first intervention)

• Change in Maternal Confidence Questionnaire (MCQ) Score

  Baseline, Week 6 (after the first intervention)

Study Arms (3)

APPLES-tele first, then PCA

EXPERIMENTAL

Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks.

Other: APPLES-tele; Behavioral: Parent-centered Approach (PCA) Support Intervention

PCA first, then APPLES-tele

EXPERIMENTAL

Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks.

Other: APPLES-tele; Behavioral: Parent-centered Approach (PCA) Support Intervention

Standard of Care Control Arm

ACTIVE COMPARATOR

Participants receiving the standard of care for 6 weeks.

Behavioral: Standard of Care

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.

Also known as: C-Mitt

APPLES-tele first, then PCA; PCA first, then APPLES-tele

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.

APPLES-tele first, then PCA; PCA first, then APPLES-tele

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.

Standard of Care Control Arm

Eligibility Criteria

• Age: 4 Months - 13 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Passive Cutaneous Anaphylaxis; Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nathalie Maitre, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Maitre, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two active treatments will be administered in different sequences, and will be compared with a standard of care study arm.

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 9, 2021
• Study Start: February 23, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)