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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Modena and Reggio Emilia
Sponsor:
Collaborator:
Azienda Unita' Sanitaria Locale Di Modena
Information provided by (Responsible Party):
Stefania Costi, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01911559
First received: July 19, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention
Cerebral Palsy
Quadriplegia
Diplegia
Constipation
Device: standing-frame

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • bowel evacuation frequency [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency


Secondary Outcome Measures:
  • Bowel evacuation inductions frequency [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Using a daily-diary where the caregivers collect the data about the pain related to the bowel evacuation

  • distress of the caregiver [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Using a daily-diary where the caregivers collect the data about the distress of the caregiver


Estimated Enrollment: 5
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911559

Locations
Italy
Local Health Institution of Modena Recruiting
Carpi, Modena, Italy, 41124
Contact: Stefania Costi, MSc    +39 0522522 ext 441    stefania.costi@unimore.it   
Principal Investigator: Elisa Fornasari, BScPT         
Sub-Investigator: Elena Rivi, BSc OT         
Sponsors and Collaborators
Stefania Costi
Azienda Unita' Sanitaria Locale Di Modena
  More Information

Publications:
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
Study First Received: July 19, 2013
Last Updated: June 23, 2014
Health Authority: Italy: National Institute of Health

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

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

ClinicalTrials.gov processed this record on August 26, 2014