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

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ClinicalTrials.gov Identifier: NCT01911559
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Cerebral Palsy Quadriplegia Diplegia Constipation Device: standing-frame

Study Design

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study
Study Start Date : January 2013
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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 Name: stander


Outcome Measures

Primary Outcome Measures :
  1. bowel evacuation frequency [ Time Frame: 14 weeks ]
    Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency


Secondary Outcome Measures :
  1. Bowel evacuation inductions frequency [ Time Frame: 14 weeks ]
    Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency


Other Outcome Measures:
  1. 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

  2. distress of the caregiver [ Time Frame: 14 weeks ]
    Using a daily-diary where the caregivers collect the data about the distress of the caregiver


Eligibility Criteria

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911559


Locations
Italy
Local Health Institution of Modena
Carpi, Modena, Italy, 41124
Sponsors and Collaborators
Stefania Costi
Azienda Unita' Sanitaria Locale Di Modena
More Information

Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 9433361
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.

Responsible Party: Stefania Costi, MSc in PT, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01911559     History of Changes
Other Study ID Numbers: standing_2013
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Stefania Costi, University of Modena and Reggio Emilia:
Standing-frame
Chronic constipation
Cerebral palsy
Quadriplegia
Severe diplegia

Additional relevant MeSH terms:
Constipation
Paralysis
Cerebral Palsy
Quadriplegia
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases