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Sitting Postural Control in Infants With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01200927
First received: September 10, 2010
Last updated: September 13, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention
Cerebral Palsy
 Other: Physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INVESTIGATION OF THE DYNAMICS OF SITTING POSTURAL CONTROL IN INFANTS WITH CEREBRAL PALSY

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Gross Motor Function Measure, Sitting Section [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    sitting skill assessment


Secondary Outcome Measures:
  • Center of pressure measures [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    linear and nonlinear measures of center of pressure in sitting


Enrollment: 35
Study Start Date: December 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Physical therapy
    Perceptual motor therapy, comparing twice weekly to once weekly home program
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.

  Eligibility

Ages Eligible for Study:   5 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200927

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Nicholas Stergiou, PhD University of Nebraska Omaha
  More Information

No publications provided by University of Nebraska

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nicholas Stergiou, University of Nebraska at Omaha
ClinicalTrials.gov Identifier: NCT01200927     History of Changes
Other Study ID Numbers: 183-02, H133G040118
Study First Received: September 10, 2010
Last Updated: September 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
infant
sitting
postural control

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013