Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy

NCT ID: NCT01911559

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy Quadriplegia Diplegia Constipation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

standing-frame

Intervention Type DEVICE

Interventions

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standing-frame

Intervention Type DEVICE

Other Intervention Names

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stander

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Unita' Sanitaria Locale Di Modena

OTHER

Sponsor Role collaborator

Stefania Costi

OTHER

Sponsor Role lead

Responsible Party

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Stefania Costi

MSc in PT

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Local Health Institution of Modena

Carpi, Modena, Italy

Site Status

Countries

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Italy

References

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Pin TW. Effectiveness of static weight-bearing exercises in children with cerebral palsy. Pediatr Phys Ther. 2007 Spring;19(1):62-73. doi: 10.1097/PEP.0b013e3180302111.

Reference Type BACKGROUND
PMID: 17304099 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

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.

View Document

Other Identifiers

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standing_2013

Identifier Type: -

Identifier Source: org_study_id

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