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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor + problem solving | Behavioral | Developmental motor tasks incorporating cognitive concepts such as object permanence |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 1 month, 2 month, 3 months, up to 9 months post baseline |
| Early Problem Solving Indicator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regina T Harbourne, PhD | Duquesne University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duquesne University | Pittsburgh | Pennsylvania | 15282 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30810750 | Derived | 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. |
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No plan to make individual participant data available
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| ID | Term |
|---|---|
| D002658 | Developmental Disabilities |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| body weight support training | Behavioral | Mobility tasks to change positions or move the body with assistance to initiate movement |
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Longitudinal Early Problem Solving Indicator 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 |