Cerebral PalsyCPNCT01911559
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Quadriplegia, run by Stefania Costi at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cerebral Palsy, Quadriplegia, Diplegia
- What is being tested?
- standing-frame
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study
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.
- Conditions
- Cerebral Palsy, Quadriplegia, Diplegia, Constipation
- Being tested
- standing-frame
- Keywords
- Standing-frame, Chronic constipation, Cerebral palsy, Quadriplegia, Severe diplegia
- Medical subject headings
- Cerebral Palsy, Quadriplegia, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standing-frameDevice
Also called stander
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: standing-frame |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel evacuation frequency
Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency
Measured: 14 weeks
Secondary outcomes (1)
Bowel evacuation inductions frequency
Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania Costi
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Unita' Sanitaria Locale Di Modena
- Responsible party
- Sponsor-investigator, Stefania Costi, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911559
- Sponsor's protocol ID
- standing_2013
- Acronym
- CP
- Status last verified
- May 2016
- First submitted
- 19 Jul 2013
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17304099
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study
- ClinicalTrials.gov ID
- NCT01911559
- Acronym / sponsor ID
- CP / standing_2013
- Conditions
- Cerebral Palsy, Quadriplegia, Diplegia, Constipation
- Keywords
- Standing-frame, Chronic constipation, Cerebral palsy, Quadriplegia, Severe diplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stefania CostiUniversity, hospital or other
- Collaborators
- Azienda Unita' Sanitaria Locale Di Modena
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| constipated quadriplegic CP children | – | Device: standing-frameIn this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standing-frameAlso: stander | Device | constipated quadriplegic CP children |
Primary outcome
bowel evacuation frequency
Time frame: 14 weeks
Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency
1 secondary outcome
Bowel evacuation inductions frequency
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Background: PubMed 17304099Pin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Quadriplegia, run by Stefania Costi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel evacuation frequency (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.