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Sitting Postural Control in Infants With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical therapy
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring infant, sitting, postural control

Eligibility Criteria

5 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • able to prop sit for 10 seconds
  • 1.5 SD below mean on Peabody motor assessment
  • between 5 months and 24 months old
  • diagnosis of CP or at risk for CP

Exclusion Criteria:

  • blindness
  • dislocated hip

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Typically Developing Infants

Home Program

Perceptual-motor intervention

Arm Description

Typically developing infants (5 months old, SD .5 months at entry) were followed longitudinally as a comparison for postural variables. The primary outcome measure is Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure.

Home program (1x/week for 8 weeks). The primary outcome measure is Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure.

Perceptual-motor intervention (2x/week for 8 weeks. The primary outcome measure is Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure.

Outcomes

Primary Outcome Measures

Gross Motor Function Measure, Sitting Section
sitting skill assessment

Secondary Outcome Measures

Center of pressure measures
linear and nonlinear measures of center of pressure in sitting

Full Information

First Posted
September 10, 2010
Last Updated
August 29, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01200927
Brief Title
Sitting Postural Control in Infants With Cerebral Palsy
Official Title
Investigation of the Dynamics of Sitting Postural Control in Infants With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2004 (Actual)
Primary Completion Date
June 1, 2008 (Actual)
Study Completion Date
June 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall goal of this research is to understand the mechanisms underlying the development of postural control in sitting using new methodology, in order to provide a scientific basis for evaluation and treatment of posture and movement disorders in infants with cerebral palsy. The development of early posture control remains poorly understood despite considerable therapeutic effort. Infants with cerebral palsy show their first delays in the acquisition of sitting, with subsequent problems developing adequate posture and movement control. Identifying the delay, determining the nature of the problem, and evaluating the effectiveness of treatment quickly, are vital in the early part of an infant's life, since this is the time of greatest plasticity. Tools from nonlinear dynamics, which are increasingly being used to examine other biological rhythms, are used in this study to analyze postural sway from center of pressure data during the development of sitting postural control.
Detailed Description
Background: The ability to sit independently is fundamental for function but delayed in infants with cerebral palsy (CP). Studies of intervention directed specifically toward sitting in infants with CP have not been reported. Objective: Our purpose was to compare two interventions for improving sitting postural control in infants with CP. Design: For this randomized longitudinal study, infants under 2 years old and at risk for CP were recruited for intervention directed toward sitting independence. Setting: The intervention was conducted at home or at an outpatient facility. Patients: Fifteen typically developing infants (5 months old, SD .5 months at entry) were followed longitudinally as a comparison for postural variables. Thirty-five infants with delays in achieving sitting were recruited. Infants with delays were randomly assigned to a home program (1x/week for 8 weeks; mean age=15.5 months, SD=7 months), or a perceptual-motor intervention (2x/week for 8 weeks; mean age=14.3 months, SD=3 months). Measurements: The primary outcome measure was Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure. Results: There was a main effect of time in the GMFM sitting subscale and in two of the COP variables. Interaction of group by time factors indicated significant differences between intervention groups on two COP measures, in favor of the group with perceptual-motor intervention. Limitations: The small number of infants limits the ability to generalize the findings. Conclusions: Although both groups made progress in the GMFM, the COP measures indicated an advantage for the group with perceptual-motor intervention. The COP measures appear sensitive for assessment of infant posture control and quantifying intervention response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
infant, sitting, postural control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Typically Developing Infants
Arm Type
No Intervention
Arm Description
Typically developing infants (5 months old, SD .5 months at entry) were followed longitudinally as a comparison for postural variables. The primary outcome measure is Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure.
Arm Title
Home Program
Arm Type
Active Comparator
Arm Description
Home program (1x/week for 8 weeks). The primary outcome measure is Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure.
Arm Title
Perceptual-motor intervention
Arm Type
Active Comparator
Arm Description
Perceptual-motor intervention (2x/week for 8 weeks. The primary outcome measure is Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Perceptual motor therapy, comparing twice weekly to once weekly home program
Primary Outcome Measure Information:
Title
Gross Motor Function Measure, Sitting Section
Description
sitting skill assessment
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Center of pressure measures
Description
linear and nonlinear measures of center of pressure in sitting
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: able to prop sit for 10 seconds 1.5 SD below mean on Peabody motor assessment between 5 months and 24 months old diagnosis of CP or at risk for CP Exclusion Criteria: blindness dislocated hip
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Stergiou, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20966212
Citation
Harbourne RT, Willett S, Kyvelidou A, Deffeyes J, Stergiou N. A comparison of interventions for children with cerebral palsy to improve sitting postural control: a clinical trial. Phys Ther. 2010 Dec;90(12):1881-98. doi: 10.2522/ptj.2010132. Epub 2010 Oct 21.
Results Reference
derived

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Sitting Postural Control in Infants With Cerebral Palsy

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