NCT01911559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.1 years

First QC Date

July 19, 2013

Last Update Submit

May 16, 2016

Conditions

Cerebral PalsyQuadriplegiaDiplegiaConstipation

Keywords

Standing-frameChronic constipationCerebral palsyQuadriplegiaSevere diplegia

Outcome Measures

Primary Outcomes (1)

  • bowel evacuation frequency

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

    14 weeks

Secondary Outcomes (1)

  • Bowel evacuation inductions frequency

    14 weeks

Other Outcomes (2)

  • pain related to the bowel evacuation

    14 weeks

  • distress of the caregiver

    14 weeks

Study Arms (1)

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

Interventions

standing-frameDEVICE
Also known as: stander
constipated quadriplegic CP children

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Health Institution of Modena

Carpi, Modena, 41124, Italy

Location

Related Publications (1)

  • Pin TW. Effectiveness of static weight-bearing exercises in children with cerebral palsy. Pediatr Phys Ther. 2007 Spring;19(1):62-73. doi: 10.1097/PEP.0b013e3180302111.

    PMID: 17304099BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyQuadriplegiaConstipation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc in PT

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 30, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

IT(1)