Cerebral PalsyNCT01200927
Sitting Postural Control in Infants With Cerebral Palsy
A study testing Physical therapy in people with Cerebral Palsy, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 24 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2004to 1 Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- blindness
- dislocated hip
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: 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.
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.
- Conditions
- Cerebral Palsy
- Being tested
- Physical therapy
- Keywords
- infant, sitting, postural control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyOther
Perceptual motor therapy, comparing twice weekly to once weekly home program
| Study group | Role | What they receive |
|---|---|---|
| Typically Developing Infants | No intervention | 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 | Active comparator | 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. Receives: Other: Physical therapy |
| Perceptual-motor intervention | Active comparator | 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. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure, Sitting Section
sitting skill assessment
Measured: 2 months
Secondary outcomes (1)
Center of pressure measures
linear and nonlinear measures of center of pressure in sitting
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study start1 Dec 2004
- Primary completion1 Jun 2008
- Study completion1 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Stergiou, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200927
- Sponsor's protocol ID
- 0183-02-FB
- Other IDs
- H133G040118
- Status last verified
- Aug 2023
- First submitted
- 10 Sep 2010
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Dynamics of Sitting Postural Control in Infants With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01200927
- Acronym / sponsor ID
- 0183-02-FB
- Conditions
- Cerebral Palsy
- Keywords
- infant, sitting, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Dec 2004 (actual)
- Primary completion
- 1 Jun 2008 (actual)
- Study completion
- 1 Jun 2008 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Typically Developing Infants | No intervention | –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 | Active comparator | Other: Physical therapyHome 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 | Active comparator | Other: Physical therapyPerceptual-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. |
Who may qualify
- Ages
- 5 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- blindness
- dislocated hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyPerceptual motor therapy, comparing twice weekly to once weekly home program | Other | Home Program, Perceptual-motor intervention |
Primary outcome
Gross Motor Function Measure, Sitting Section
Time frame: 2 months
sitting skill assessment
1 secondary outcome
Center of pressure measures
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 20966212Harbourne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Stergiou, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy in people with Cerebral Palsy, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure, Sitting Section (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01200927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.