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

Sponsor

Stefania Costi (Other)

Overall Status

Completed

CT.gov ID

NCT01911559

Collaborator

Azienda Unita' Sanitaria Locale Di Modena (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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	Phase
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 :

Jan 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

bowel evacuation frequency [14 weeks]
Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency

Secondary Outcome Measures

Bowel evacuation inductions frequency [14 weeks]
Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency

Other Outcome Measures

pain related to the bowel evacuation [14 weeks]
Using a daily-diary where the caregivers collect the data about the pain related to the bowel evacuation
distress of the caregiver [14 weeks]
Using a daily-diary where the caregivers collect the data about the distress of the caregiver

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.