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Completed

NCT Number: NCT01911559

Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Constipation Diplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Signs and Symptoms, Digestive

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Health Institution of Modena

Carpi, Modena, 41124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standing-frame

Device

Other names: stander

Primary outcomes

  1. bowel evacuation frequency

    Time frame: 14 weeks

    Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency

Secondary outcomes

  1. Bowel evacuation inductions frequency

    Time frame: 14 weeks

    Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency

Other outcomes

  1. pain related to the bowel evacuation

    Time frame: 14 weeks

    Using a daily-diary where the caregivers collect the data about the pain related to the bowel evacuation

  2. distress of the caregiver

    Time frame: 14 weeks

    Using a daily-diary where the caregivers collect the data about the distress of the caregiver

Sponsors and collaborators

Lead sponsor

Stefania Costi

Other

Collaborators

  • Azienda Unita' Sanitaria Locale Di Modena

Registry information

Official study title

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

Acronym: CP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2013
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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