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CompletedNCT01200927Updated Sep 1, 2023

Sitting Postural Control in Infants With Cerebral Palsy

An interventional study of Physical therapy in Cerebral Palsy, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 5 Months to 24 Months. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Dec 2004, registered Sep 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
5 Months to 24 Months
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Cerebral Palsy

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Keywords

  • infant
  • sitting
  • postural control
03

In context

Cerebral Palsy

1,852 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.

This study's enrollment of 35 is close to the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • blindness
  • dislocated hip
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • No intervention
    Typically Developing Infants

    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.

  • Active comparator
    Home Program

    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.

    Other: Physical therapy

  • Active comparator
    Perceptual-motor intervention

    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.

    Other: Physical therapy

Interventions

  • OtherPhysical therapy

    Perceptual motor therapy, comparing twice weekly to once weekly home program

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What researchers measure

Primary outcomes

  1. Gross Motor Function Measure, Sitting Section

    sitting skill assessment

    Time frame: 2 months

Secondary outcomes

  1. Center of pressure measures

    linear and nonlinear measures of center of pressure in sitting

    Time frame: 2 months

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Study locations

1 site
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
08

References and documents

Publications

  • 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. PubMed 20966212 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01200927
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Sep 14, 2010
Start date
Dec 1, 2004
Primary completion
Jun 1, 2008
Completion
Jun 1, 2008
Last update
Sep 1, 2023

Study contacts

Nicholas Stergiou, PhD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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