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Project for Cognitive Advancement in Infants With Neuromotor Disorders (CAN-Do)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673658
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Duquesne University

Tracking Information
First Submitted Date  ICMJE January 29, 2016
First Posted Date  ICMJE February 4, 2016
Last Update Posted Date February 18, 2019
Study Start Date  ICMJE October 2015
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2016)
Gross Motor Function Measure [ 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Gross Motor Function Measure [ Time Frame: 12 months ]
Longitudinal Gross Motor Function Measure change measures from baseline to: 1 month, 2 months, 3 months and 9 months post intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2016)
  • Visual attention - time to switch between 2 targets, and look time [ 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
  • Early Problem Solving Indicator [ 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
  • Visual attention - time to switch between 2 targets, and look time [ Time Frame: 12 months ]
    Longitudinal eye tracking change measures from baseline to: 1 month, 2 months, 3 months and 9 months post intervention
  • Early Problem Solving Indicator [ Time Frame: 12 months ]
    Longitudinal Early Problem Solving Indicator change measures from baseline to:, 1 month, 2 months, 3 months and 9 months post
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project for Cognitive Advancement in Infants With Neuromotor Disorders
Official Title  ICMJE Project for Cognitive Advancement in Infants With Neuromotor DisOrders:The CAN-DO Project
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Motor Coordination or Function; Developmental Disorder
Intervention  ICMJE
  • Behavioral: Motor + problem solving
    Developmental motor tasks incorporating cognitive concepts such as object permanence
  • Behavioral: body weight support training
    Mobility tasks to change positions or move the body with assistance to initiate movement
Study Arms  ICMJE
  • Active Comparator: Motor + problem solving
    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.
    Intervention: Behavioral: Motor + problem solving
  • Active Comparator: Body weight support training
    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.
    Intervention: Behavioral: body weight support training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
24
Actual Study Completion Date  ICMJE February 14, 2019
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants with a diagnosis of a neuromotor disorder such as cerebral palsy, or a birth history and developmental history indicative of cerebral palsy (prematurity, intraventricular hemorrhage, periventricular leukomalacia) will be selected for this study. The infants will be at Gross Motor Function Classification Scale (GMFCS) levels I, II, or III, because infants at levels IV and V would be unlikely to reach the level of sitting independence to enter the study. Additional behavioral inclusion criteria are: between the ages of 9 months and 3 years at the time of entry into the study; the child should already be independent in prop sitting (sitting with arm support) for at least 1 minute, and be able to lift one arm up in sitting (after being placed in sitting) to reach for a toy placed directly in front of them without losing balance

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02673658
Other Study ID Numbers  ICMJE 4100068712 Project 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No plan to make individual participant data available
Responsible Party Duquesne University
Study Sponsor  ICMJE Duquesne University
Collaborators  ICMJE Pennsylvania Department of Health
Investigators  ICMJE
Principal Investigator: Regina T Harbourne, PhD Duquesne University
PRS Account Duquesne University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP