Clinical trial NCT04997109: Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
Official title: Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-08-09
Enrollment: 267
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two active treatments will be administered in different sequences, and will be compared with a standard of care study arm.
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Cerebral palsy (CP) is a disorder characterized by impairments of sensorimotor function resulting from neural insults in the perinatal period. Every year almost 10,000 children are born with CP in the US. CP incidence ranges from 2 to 3 per 1000 in North America, Australia, and Europe and is difficult to estimate in the developing world. Intervention strategies to promote function of children with CP must be adaptable to settings where resources or access may be limited, yet simultaneously integrate best clinical evidence and neuroscientific principles. Upper extremity (UE) impairments are present in a significant portion of children with CP, some with hemiplegia (\~25% children with CP), and others with quadriplegia, in which one arm and hand may be more affected than the other (another \~25%). UE impairments in CP result from a combination of motor and sensory dysfunctions including a lack of high-quality motor experience, which combined with "noisy" (often faulty) sensory input, challenges the acquisition of new effective motor patterns.

Among the various approaches to improve UE function in infants with CP are constraint-induced movement therapy (the use of constraints on less affected limbs) and bimanual therapy (training of both extremities in coordination). Brief sessions of parent-delivered, infant-initiated, goal-directed, success-motivated and repetitive activity in enriched sensory environments can be effective, while respecting fundamental principles of infant development and home life. Parent administration of the intervention helps preserve the integrity of early parent-child relationships, critical to establishment of infants' sense of self, safety, and independence.

Finally, to take full advantage of neuroplasticity and maximize potential downstream developmental effects, it is essential to intervene as early as possible in children with CP. Promising new treatments such as transcranial magnetic stimulation, robotic-assisted movements and technology enhancements to movement feedback are in development. However, these interventions require substantial investments of highly-skilled therapists, technology, infrastructure and access to academic facilities. While the new interventions advance the cutting-edge of motor intervention development, on another leading edge, parent-delivered therapist-directed telehealth interventions are becoming more widespread, addressing a critical need for lower-resource interventions.

Healthcare systems resources are limited, and can be difficult to access due to geographic and socioeconomic obstacles. While telehealth therapy seems eminently practical, and a natural extension of current interventions for infants with CP, it faces its own scientific challenges. The same essential attributes of physical therapy that make it so effective in person can make it difficult to deliver via telehealth. Telehealth therapy in infants requires a level of parent engagement, knowledge and parenting skills that is sometimes lacking. Feasible telehealth interventions to improve function in infants with CP must also address the challenges faced by their parents in conducting the sessions through effective parenting supports.

In this study, infant participants with CP will be randomized to one of three treatment groups:

1. The APPLES intervention via telehealth (APPLES-tele) followed by a parent-centered approach (PCA) intervention
2. The PCA intervention followed by the APPLES-tele intervention
3. The standard of care

Outcome measures will be standardized assessments of hand/arm function and validated parent-report measures of infant motor activity.

Eligibility criteria: Inclusion Criteria:

* Aged 4 to 13 months, corrected age
* Patient at a participating neonatal intensive care unit (NICU) Early Developmental Clinic, outpatient physical and occupational therapy clinic and stroke clinic
* 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

Primary outcomes:
measure: Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score
timeFrame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
measure: Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score
timeFrame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
Secondary outcomes:
measure: Change in Infant Motor Activity Log (IMAL) How Often Score
timeFrame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
measure: Change in Hand Assessment in Infants (HAI) Score
timeFrame: Baseline, Week 6 (after the first intervention)
measure: Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score
timeFrame: Baseline, Week 6 (after the first intervention)
measure: Change in Welch Emotional Connection Screen (WECS) Score
timeFrame: Baseline, Week 6 (after the first intervention)
measure: Change in Maternal Confidence Questionnaire (MCQ) Score
timeFrame: Baseline, Week 6 (after the first intervention)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
Study officials:
affiliation: Emory University
name: Nathalie Maitre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: