Project for Cognitive Advancement in Infants With Neuromotor Disorders
Condition: Motor Coordination or Function; Developmental Disorder
MeSH terms: Developmental Disabilities
Study type: Interventional

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.
    

Detailed description: 
      This longitudinal study will examine the ongoing interaction between the domains of cognitive
      and motor development in infants with neuromotor disability, as well as compare differences
      between groups of infants receiving two types of intervention.

      The specific aims for this study are:

        1. To measure the changes of the head, trunk and pelvis as the primary orienting segments
           of the body during the achievement of sitting and the transition to crawling in infants
           with neuromotor disability.

        2. Describe the changes in problem-solving and cognitive abilities of infants with
           neuromotor disability as they transition to stable sitting and then to crawling.

        3. Using eye-tracking technology, quantify the evolution of focused attention in infants
           with neuromotor disability as the motor skills of sitting and the transition to crawling
           emerge.

        4. Compare motor skill, visual attention and cognitive change as sitting and crawling
           emerge between groups of infants with neuromotor disabilities receiving two different
           interventions, and determine the effects of distinctly different paradigms: one that
           focuses simply on building motor skill, and the other that builds motor and cognition
           together.

      This is a longitudinal study, with between group comparisons to determine the effectiveness
      of the intervention, and within group comparisons to determine change over time. Measures
      will occur in the home at baseline, at the end of month 1 of intervention, the end of month
      2, the end of month 3, and at a 9 month follow-up visit, for a total of 5 measurement times.
      Each session will take approximately 1 hour each time. Because we want to look at the child's
      movement and posture, the child should be clothed in either an undergarment or a bathing suit
      that allows a view of their trunk, legs and arms during the 5 measurement sessions. We will
      video the child's movement and posture and play doing two standardized infant tests during
      these measurement sessions. The child will sit on the floor as independently as they can and
      reach for toys and move through as many developmental postures as they can (crawling, pulling
      to stand, moving in and out of sitting). The parent will always be next to their child during
      measurement sessions.

      Children will participate in one of the parent-delivered interventions for 3-months after
      being randomized to one of two groups. Both intervention groups are parent-delivered
      interventions, with differing goals and differing training. Parents will be trained in one of
      the following approaches:

      Motor-based problem solving approach or the body weight support (BWS) approach.

      In both of the above approaches, parents will receive weekly, one-hour sessions at home for
      updates and training from a physical therapist to advance the program for individual infants.
      Thus, there will be a total of 12 sessions with a therapist. Each program is individualized
      because no two infants will have exactly the same skill set. This individualization of
      programs is standard practice for early intervention. Generally, the suggestions will follow
      standard developmental guidelines, with sequencing of skills presented in the order of normal
      development. Both of these approaches are currently used in early intervention for young
      children with developmental disabilities, but we do not know which is more effective, or if
      either approach is effective.
    

Intervention name(s): Motor + problem solving; body weight support training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Developmental motor tasks incorporating cognitive concepts such as object permanence; Mobility tasks to change positions or move the body with assistance to initiate movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: infant development, early intervention