- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01200927
Sitting Postural Control in Infants With Cerebral Palsy
August 29, 2023 updated by: University of Nebraska
Investigation of the Dynamics of Sitting Postural Control in Infants With Cerebral Palsy
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.
Study Overview
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
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 2 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Perceptual motor therapy, comparing twice weekly to once weekly home program
|
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.
|
Perceptual motor therapy, comparing twice weekly to once weekly home program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function Measure, Sitting Section
Time Frame: 2 months
|
sitting skill assessment
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center of pressure measures
Time Frame: 2 months
|
linear and nonlinear measures of center of pressure in sitting
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicholas Stergiou, PhD, University of Nebraska
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2004
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
September 10, 2010
First Submitted That Met QC Criteria
September 13, 2010
First Posted (Estimated)
September 14, 2010
Study Record Updates
Last Update Posted (Actual)
September 1, 2023
Last Update Submitted That Met QC Criteria
August 29, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0183-02-FB
- H133G040118 (Other Grant/Funding Number: Dept of Education, NIDRR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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