Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy

Completed

• Conditions: Quadriplegia; Diplegia; Cerebral Palsy; Constipation
• Interventions: Device: standing-frame

• Registration Number: NCT01911559
• Lead Sponsor: Stefania Costi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
constipated quadriplegic CP children	standing-frame	In this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame.

Primary Outcome Measures

Name	Time	Method
bowel evacuation frequency	14 weeks	Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency

Secondary Outcome Measures

Name	Time	Method
Bowel evacuation inductions frequency	14 weeks	Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency

Trial Locations

Locations (1)

Local Health Institution of Modena; 🇮🇹 Carpi, Modena, Italy