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Sitting Postural Control in Infants With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01200927
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Physical therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INVESTIGATION OF THE DYNAMICS OF SITTING POSTURAL CONTROL IN INFANTS WITH CEREBRAL PALSY
Study Start Date : December 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: Physical therapy
    Perceptual motor therapy, comparing twice weekly to once weekly home program


Primary Outcome Measures :
  1. Gross Motor Function Measure, Sitting Section [ Time Frame: 2 months ]
    sitting skill assessment


Secondary Outcome Measures :
  1. Center of pressure measures [ Time Frame: 2 months ]
    linear and nonlinear measures of center of pressure in sitting



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Ages Eligible for Study:   5 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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

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): 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

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 ( Other Grant/Funding Number: Dept of Education, NIDRR )
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Keywords provided by University of Nebraska:
infant
sitting
postural control

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