- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911559
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy (CP)
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study
Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced mobility and consequent constipation. Clinicians frequently recommend standing-frames to exercise the support reaction in this population, sharing the opinion that the upright position may facilitate intestinal transit, although no evidence supports this assumption.
The investigators conducted this single-subject research to determine the effects of the standing-frame on the frequency of evacuation in chronically constipated children with CP and quadriplegia.
Moreover, the investigators studied its effects on the frequency of induction of evacuation, the characteristics of the stool and the pain suffered by the child due to constipation and/or evacuation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Modena
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Carpi, Modena, Italy, 41124
- Local Health Institution of Modena
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria were:
- clinical indication for the use of the standing-frame;
- constipation problems as defined by guidelines (Clinical Practice Guideline, 2006);
- whose parents gave the informed consent to let their child to participate in this study.
Exclusion criteria were:
- children who have orthosympathetic reactions to the upright position, skeletal deformities and/or medical conditions that, according to clinical judgment, advise against the use of the standing frame.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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constipated quadriplegic CP children
In this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bowel evacuation frequency
Time Frame: 14 weeks
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Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency
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14 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bowel evacuation inductions frequency
Time Frame: 14 weeks
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Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency
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14 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain related to the bowel evacuation
Time Frame: 14 weeks
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Using a daily-diary where the caregivers collect the data about the pain related to the bowel evacuation
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14 weeks
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distress of the caregiver
Time Frame: 14 weeks
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Using a daily-diary where the caregivers collect the data about the distress of the caregiver
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14 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- standing_2013
Plan for Individual participant data (IPD)
Study Data/Documents
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Clinical Study Report
Information identifier: 9433361Information comments: Rivi, Elena & Filippi, Mariacristina & Fornasari, Elisa & Mascia, Maria Teresa & Ferrari, Adriano & Costi, Stefania. (2014). Effectiveness of Standing Frame on Constipation in Children with Cerebral Palsy: A Single-Subject Study. Occupational therapy international.
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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