N/A
N=134
Efficacy of the START-Play Program for Infants With Neuromotor Disorders
Cerebral Palsy · Developmental Delay · Infant Development
Bottom Line
View on ClinicalTrials.gov: NCT02593825 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Bayley Scales of Infant Development III — 35.9; 33.6; 31.7; 29.4 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- START-Play intervention (Behavioral); Business as usual (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Duquesne University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bayley Scales of Infant Development III |
35.9; 33.6; 31.7; 29.4; 39.3; 37.3 | <0.05 sig |
| SECONDARY Change in Modified Parent Child Interaction-Dyadic Mini Code |
.22; .19; .46; .34; .49; .46 | .05 |
| SECONDARY Change in Frequency (Number) of Toy Contacts |
13.1; 13; 7.2; 9.3; 18.2; 16.5 | <0.05 sig |
| SECONDARY Change in Duration (Time) of Toy Contacts |
38.20; 42.28; 44.93; 47.38; 46.87; 44.35 | — |
| SECONDARY Change in Gross Motor Function Measure, Sitting Subscale |
35; 31.3; 26.3; 20.9; 41.9; 40.6 | <0.05 sig |
| SECONDARY Change in Early Problem Solving Indicator (EPSI) |
64.5; 59.2; 57.7; 46.9; 70; 70.2 | <0.05 sig |
| SECONDARY Change in Reaching (Change in Looking and Hand Contact of Toy) |
4.06; 5.96; 7.45; 7.14; 10.83; 7.69 | 0.417 |
Summary
The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.
Eligibility Criteria
Inclusion Criteria
- • Infants enter study between 7-16 months of age, when they are able to prop sit for 3 seconds and maintain their head at least to the level of neutral alignment with their trunk.
- Gross motor delay as reflected in the Bayley III motor subtest >1.0 Standard Deviation below the mean.
- Neuromotor disorder such as cerebral palsy (CP), or at risk for CP because of extreme prematurity or brain damage that occurred at or around birth, or infants with motor delay of an unspecified origin (no clear diagnosis, but delay as above) -• Minimal movement requirements/Indicators of readiness for change: Sits with support of arms for 3 seconds after being placed. Exhibits at least some spontaneous movement of arms.
Exclusion Criteria
- • Medical complications that severely limit participation in assessments and intervention such as severe visual and congenital/genetic anomalies, uncontrolled seizure disorder.
- Diagnosis other than an unchanging neuromotor disorder (examples: autism, Down syndrome, spinal cord injury, acquired head injury, muscle disorder).
- A child will be excluded if the parents report any of following: 1) if the child has a disability of a progressive nature such as muscular dystrophy; 2) if the child's family plans to move out of the local area within one year from the start of the study; 3) if the child has major surgery planned that might affect physical performance.
Data sourced from ClinicalTrials.gov (NCT02593825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.