Duquesne University
Pittsburgh, Pennsylvania, 15282, United States
NCT Number: NCT02673658
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.
Looking for future studies?
Notify Me7 month–36 month
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15282, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Developmental motor tasks incorporating cognitive concepts such as object permanence
Mobility tasks to change positions or move the body with assistance to initiate movement
Time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
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
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
Longitudinal Early Problem Solving Indicator change measures from baseline to:,
1 month, 2 months, 3 months and 9 months post baseline
Duquesne University
Other
Project for Cognitive Advancement in Infants With Neuromotor DisOrders:The CAN-DO Project
Acronym: CAN-Do
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07547514
Cognitive Ability General, Development Coordination Disorder
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07427706
Apgar Score, Behavior
Tarragona, Reus, Spain
View Trial DetailsNCT06390072
Ankle Injuries, Ankle Sprains
Athens, Ohio, United States
View Trial DetailsNCT06125613
Acute Pain, Anxiety Disorders
Lille, Nord, France
View Trial Details