Project for Cognitive Advancement in Infants With Neuromotor Disorders

Completed · Not applicable

Conditions studied: Motor Coordination or Function; Developmental Disorder

In brief

The purpose of this longitudinal study is to examine the ongoing interaction between the domains of cognitive and motor development in infants with neuromotor disability, and to compare outcomes of two groups of infants receiving two different types of home-based, parent-delivered physical therapy intervention, in order to determine which intervention is more effective in advancing cognitive as well as motor development. Knowledge of the effectiveness of two types of intervention will lead to improved early intervention for children with developmental disabilities, as well as future studies to examine ongoing outcomes.

Key facts

Study ID

NCT02673658

Run by

Duquesne University

People needed

20

Starts

2015-10-01

Expected to finish

2019-02-14

Last updated by the study team

2019-02-18

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants with a diagnosis of a neuromotor disorder such as cerebral palsy, or a birth history and developmental history indicative of cerebral palsy (prematurity, intraventricular hemorrhage, periventricular leukomalacia) will be selected for this study. The infants will be at Gross Motor Function Classification Scale (GMFCS) levels I, II, or III, because infants at levels IV and V would be unlikely to reach the level of sitting independence to enter the study. Additional behavioral inclusion criteria are: between the ages of 9 months and 3 years at the time of entry into the study; the child should already be independent in prop sitting (sitting with arm support) for at least 1 minute, and be able to lift one arm up in sitting (after being placed in sitting) to reach for a toy placed directly in front of them without losing balance

You may not qualify if…

• blindness, dislocated hip, pending orthopedic or neurologic surgery which would interrupt the time period of the intervention, additional diagnosis that affects the neuromuscular system such as spina bifida. A child would not qualify for the study if sitting skills were mature. Mature sitting is operationally defined as: the ability to sit independently without using the arms for support for five minutes or more without falling; reaching for toys using both hands at once without disrupting balance; moving in and out of the sitting position independently.

Where it is running

• Duquesne University — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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