Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— CP  

Official title:

Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911559
• Other study ID #: standing_2013
• Status: Completed
• Phase: N/A
• First received: July 19, 2013
• Last updated: May 16, 2016
• Start date: January 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2016
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Palsy
• Constipation
• Diplegia
• Quadriplegia

Intervention

Device:
• standing-frame

Locations

Country	Name	City	State
Italy	Local Health Institution of Modena	Carpi	Modena

Sponsors (2)

Lead Sponsor	Collaborator
Stefania Costi	Azienda Unita' Sanitaria Locale Di Modena

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Pin TW. Effectiveness of static weight-bearing exercises in children with cerebral palsy. Pediatr Phys Ther. 2007 Spring;19(1):62-73. Review. Erratum in: Pediatr Phys Ther. 2007 Summer;19(2):172-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pain related to the bowel evacuation	Using a daily-diary where the caregivers collect the data about the pain related to the bowel evacuation	14 weeks	No
Other	distress of the caregiver	Using a daily-diary where the caregivers collect the data about the distress of the caregiver	14 weeks	No
Primary	bowel evacuation frequency	Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency	14 weeks	No
Secondary	Bowel evacuation inductions frequency	Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency	14 weeks	No