Project for Cognitive Advancement in Infants With Neuromotor Disorders

NCT02673658 | Completed

• 1 other identifier: 4100068712 Project 1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motor Coordination or Function; Developmental Disorder

Keywords

infant development, early intervention

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure

  Longitudinal Gross Motor Function Measure change measures from baseline to: 1 month, 2 months, 3 months and 9 months post baseline

  baseline, 1 month, 2 month, 3 months, up to 9 months post baseline

Secondary Outcomes (2)

• Visual attention - time to switch between 2 targets, and look time

  baseline, 1 month, 2 month, 3 months, up to 9 months post baseline

• Early Problem Solving Indicator

  baseline, 1 month, 2 month, 3 months, up to 9 months post baseline

Study Arms (2)

Motor + problem solving

ACTIVE COMPARATOR

This method focuses on spontaneous movement (rather than facilitated movement). Self-initiated, functionally directed movement is emphasized. Intervention includes guidance and cues, which gently call the child's attention to the support surface, and a set-up of the environment for small increments of movement so that the child can solve a movement problem. Passive movements are not used. Each small increment of movement to advance sitting skill or other motor skills is paired with a specific object or toy that challenges a cognitive concept for spatial problem solving. In this approach, the parent will adjust toys and supports to encourage changes of position from sitting, to transitions in and out of sitting to crawling or standing, but will not assist the child physically.

Behavioral: Motor + problem solving

Body weight support training

ACTIVE COMPARATOR

In this approach, infants will be supported physically by their parents to take steps, sit, crawl, or reach, in practice sessions focused simply on the motor skill. Toys or problem solving will not be part of this intervention, but the child will be assisted (lifted by the parent) through movement to improve strength and learn specific movements and new positions. The child will be able to perform as much of the movement as possible, but the parents will initiate the activity if the child does not initiate, and the parent will lift the child passively through the task if the child is unable to move.

Behavioral: body weight support training

Interventions

Motor + problem solving BEHAVIORAL

Developmental motor tasks incorporating cognitive concepts such as object permanence

Motor + problem solving

body weight support training BEHAVIORAL

Mobility tasks to change positions or move the body with assistance to initiate movement

Body weight support training

Eligibility Criteria

• Age: 7 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Duquesne University: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

Related Publications (1)

• Harbourne RT, Berger SE. Embodied Cognition in Practice: Exploring Effects of a Motor-Based Problem-Solving Intervention. Phys Ther. 2019 Jun 1;99(6):786-796. doi: 10.1093/ptj/pzz031.

  PMID: 30810750 DERIVED

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Regina T Harbourne, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 4, 2016
• Study Start: October 1, 2015
• Primary Completion: December 15, 2018
• Study Completion: February 14, 2019
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

US (1)