Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    harbourne

Efficacy of the START-Play Program for Infants With Neuromotor Disorders (START-Play)

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: NCT02593825
Recruitment Status : Active, not recruiting
First Posted : November 1, 2015
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborators:
University of Delaware
Virginia Commonwealth University
University of Washington
University of Nebraska Lincoln
Information provided by (Responsible Party):
Duquesne University

Brief Summary:
The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Developmental Delay Infant Development Behavioral: START-Play intervention Behavioral: Business as usual Not Applicable

Detailed Description:

Setting: The research will take place in the homes of infants and their families in Pennsylvania, Delaware, Washington, and Virginia.

Sample: There will be approximately 140 infants with neuromotor disorders completing participation in this study, beginning at the age the age of 7 to 16 months, as well as their families and interventionists. Infants will have gross motor delays but be able to sit propped up for at least 3 seconds when they are recruited for participation.

Intervention: Sitting Together And Reaching To Play (START-Play) is an intervention for infants with motor dysfunction or delay in which physical therapists visit the child's home to target work on siting, reaching, and problem solving. The therapist visits the home twice weekly for 3 months. During these visits, therapists and families work together to provide intensive, individualized, daily activities to advance reaching and sitting through small increments of challenge and support for these skills, which then become the building blocks for motor-based problem solving. More specifically, the intervention focuses on self-initiated, goal-directed movements to build orientation and attention to objects, while learning basic relationships of cause and effect. Infants and families in the intervention group will receive this intervention in addition to their usual early intervention services.

Research Design and Methods: This study will use a randomized controlled trial in which infants and their families are randomly assigned to the intervention group (START-Play in addition to usual services) or control group (usual early intervention services), stratified by severity of neuromotor disorder. There will be six measurement sessions during the 12-week intervention period, following by assessments during 1-, 3-, and 9-month follow-up visits. The study aims to determine the efficacy of the intervention on sitting and reaching (proximal outcomes) and motor-based problem solving skills (longer-term proximal outcome), which is hypothesized to serve as mediators to the more distal outcomes of global cognitive development and readiness to learn. The investigators will also explore fidelity of implementation to identify conditions that support fidelity and outcomes, as well as identify other moderating factors related to the child (severity of disorder, health, age, cognitive skill at entry), family (socioeconomic status, home environment), or services (fidelity of implementation, other services provided to child) to explore change over time.

Control Condition: Infants and their families in the control condition will continue to receive their regular Part C early intervention services.

Key Measures: Primary outcome measures in the study include the Gross Motor Function Measure and an observational measure of toy contacts for sitting and reaching, and the Individual and Growth Development Indicators (Early Problem Solving Indicator) and Bayley Scales of Infant and Toddler Development -Third Edition for problem solving and global development. Secondary measures include additional measures of postural control and reaching, child and family characteristics, and fidelity of implementation (logs and checklist).

Data Analytic Strategy: The investigators will use linear mixed modeling (LMM) to determine the efficacy of the intervention on child outcomes. Parallel process growth modeling within a structural equation modeling framework will be used to examine whether improvements in sitting and reaching are mediators leading to improvements in problem solving, which is then a mediator leading to long-term global cognitive development. LMM will also be used to examine moderating variables, as well as secondary motor outcomes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the START-Play Program for Infants With Neuromotor Disorders
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2022

Arm Intervention/treatment
Experimental: START-Play intervention
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
Behavioral: START-Play intervention
The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
Other Name: Perceptual motor early intervention for infants

Active Comparator: Business as Usual
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Behavioral: Business as usual
May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
Other Name: Early intervention, physical therapy




Primary Outcome Measures :
  1. Bayley Scales of Infant Development III [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months post-baseline ]
    Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome


Secondary Outcome Measures :
  1. Change in Modified Parent Child Interaction-Dyadic Mini Code [ Time Frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline ]
    Play and interaction of parent and child, coding of behavior frequency and type of interaction

  2. Change in Postural Measure of Trunk Angles [ Time Frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline ]
    kinematic measure of pelvic and trunk sagittal angle in sitting

  3. Change in Frequency (Number) of Toy Contacts [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
    behavioral coding of play and hand use, coded from videotape; Coding software used to time contacts during standard reaching task during 5 minute reaching at shoulder level and below.

  4. Change in Duration (Time) of Toy Contacts [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
    coding number seconds of videotaped hand use during play; timing coded in a video coding software for behavioral analysis Higher score=better

  5. Change in Gross Motor Function Measure, Sitting Subscale [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
    Gross motor skills in the sitting subsection of the Gross Motor Function Measure (GMFM) Minimum value=4 Maximum value=60 Higher scores=better outcome

  6. Change in Early Problem Solving Indicator (EPSI) [ Time Frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline ]
    Infant growth and development indicator of problem solving skills, adapted for children with motor deficits Modified to Assessment of Problem-Solving in Play (APSP) Minimum=30 Maximum=120 Higher=better outcome

  7. Change in Reaching (Change in Duration and Hand of Toy Contacts) [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
    Time of toy contacts, whether reach is one or two handed, higher number is better outcome, will indicate bilateral or unilateral



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Months to 16 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Infants enter study between 7-16 months of age, when they are able to prop sit for 3 seconds and maintain their head at least to the level of neutral alignment with their trunk.

    • Gross motor delay as reflected in the Bayley III motor subtest >1.0 Standard Deviation below the mean.
    • Neuromotor disorder such as cerebral palsy (CP), or at risk for CP because of extreme prematurity or brain damage that occurred at or around birth, or infants with motor delay of an unspecified origin (no clear diagnosis, but delay as above) -• Minimal movement requirements/Indicators of readiness for change: Sits with support of arms for 3 seconds after being placed. Exhibits at least some spontaneous movement of arms.

Exclusion Criteria:

  • • Medical complications that severely limit participation in assessments and intervention such as severe visual and congenital/genetic anomalies, uncontrolled seizure disorder.

    • Diagnosis other than an unchanging neuromotor disorder (examples: autism, Down syndrome, spinal cord injury, acquired head injury, muscle disorder).
    • A child will be excluded if the parents report any of following: 1) if the child has a disability of a progressive nature such as muscular dystrophy; 2) if the child's family plans to move out of the local area within one year from the start of the study; 3) if the child has major surgery planned that might affect physical performance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593825


Locations
Layout table for location information
United States, Pennsylvania
Duquesne University
Pittsburgh, Pennsylvania, United States, 15282
Sponsors and Collaborators
Duquesne University
University of Delaware
Virginia Commonwealth University
University of Washington
University of Nebraska Lincoln
Investigators
Layout table for investigator information
Principal Investigator: Regina T Harbourne, PhD Duquesne University
Principal Investigator: Sarah W McCoy, PhD University of Washington
Principal Investigator: Michele A. Lobo, PhD University of Delaware
Principal Investigator: Stacey C. Dusing, PhD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Duquesne University:
Study Protocol  [PDF] July 17, 2015
Statistical Analysis Plan  [PDF] July 17, 2015

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duquesne University
ClinicalTrials.gov Identifier: NCT02593825    
Other Study ID Numbers: R324A150103
First Posted: November 1, 2015    Key Record Dates
Results First Posted: September 1, 2020
Last Update Posted: September 1, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases