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NCT02593825 · ClinicalTrials.gov registry record · NA
Efficacy of the START-Play Program for Infants With Neuromotor Disorders
A NA study, sponsored by Duquesne University.
- Completed
- Registry status
- NA
- Development phase
- 134
- Enrollment target
NCT02593825: Completed NA study, sponsored by Duquesne University.
NCT02593825 is a NA study that has completed, run by Duquesne University. The registered enrollment target is 134 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02593825, a NA study, has completed, sponsored by Duquesne University.
- COMPLETED
- Registry status
- NA
- Development phase
- 134 participants
- Enrollment target
Study 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.
Primary Outcome
Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome
Interventions
- BEHAVIORAL START-Play intervention
- BEHAVIORAL Business as usual
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2016-01 |
| Est. Completion | 2022-06-12 |
| Phase | NA |
What the finished NCT02593825 record still lists
NCT02593825 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which START-Play intervention is the first listed.
NCT02593825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02593825 about?
NCT02593825 is a clinical study titled "Efficacy of the START-Play Program for Infants With Neuromotor Disorders". 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 lim...
What is the current status of trial NCT02593825?
This trial is currently completed. It is a NA study. The enrollment target is 134 participants. The study started on 2016-01. Estimated completion is 2022-06-12.
What interventions are being tested in trial NCT02593825?
The interventions under investigation include: START-Play intervention (BEHAVIORAL), Business as usual (BEHAVIORAL).
Who is sponsoring clinical trial NCT02593825?
This trial is sponsored by Duquesne University, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02593825's enrollment target sits among peer trials
134 728th of 2000 higher than 1,272 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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