An interventional study of Motor + problem solving and body weight support training in Motor Coordination or Function; Developmental Disorder, sponsored by Duquesne University. Completed at 1 site in United States. Open to participants aged 7 Months to 36 Months. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by Duquesne University · Not applicable, Interventional, and Treatment
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.
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:
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.
285 studies on the registry are indexed under Developmental Disabilities; 64 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 199 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →Duquesne University is the lead sponsor of 26 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Developmental motor tasks incorporating cognitive concepts such as object permanence
Mobility tasks to change positions or move the body with assistance to initiate movement
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
Time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Visual attention - time to switch between 2 targets, and look time
Longitudinal eye tracking change measures from baseline to: 1 month, 2 months, 3 months and 9 months post baseline
Time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Early Problem Solving Indicator
Longitudinal Early Problem Solving Indicator change measures from baseline to:, 1 month, 2 months, 3 months and 9 months post baseline
Time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Plan to share: Undecided — No plan to make individual participant data available
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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