Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy (CP)

May 16, 2016 updated by: Stefania Costi

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

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

  • Italy
    • Modena
      • Carpi, Modena, Italy, 41124
        • Local Health Institution of Modena

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

3 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame. The population of interest might be referred to the Unit for severe disability in developmental age or to one of the neuro-psychiatric and rehabilitation Units of the area of Modena and Reggio Emilia, (5.000 km2 of surface and 1.250.000 inhabitants)

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

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: standing-frame
Other Names:
  • stander

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bowel evacuation frequency
Time Frame: 14 weeks
Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel evacuation inductions frequency
Time Frame: 14 weeks
Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency
14 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain related to the bowel evacuation
Time Frame: 14 weeks
Using a daily-diary where the caregivers collect the data about the pain related to the bowel evacuation
14 weeks
distress of the caregiver
Time Frame: 14 weeks
Using a daily-diary where the caregivers collect the data about the distress of the caregiver
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefania Costi

Collaborators

Azienda Unita' Sanitaria Locale Di Modena

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.

General Publications

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

January 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • standing_2013

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 9433361
    Information 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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