Adult Patients With Neuromuscular Disorders Using WheelchairNCT02141724
Wheelchair Positioning and Pain in Neuromuscular Patients
An observational study of Adult Patients With Neuromuscular Disorders Using Wheelchair, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
A retrospective study with the patients having a positioning consultation at hospital, between 2009 and 2014. In every neuromuscular disorder, the investigators describe the population seen in consultation, the aim of consultation, the postural problem observed in wheelchair, pain when sitting in wheelchair, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients With Neuromuscular Disorders Using Wheelchair
- What is being tested?
- Positioning consultation
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients with neuromuscular disordres using wheelchair.
Who may be able to join
- Adult patient with neuromuscular disorder
- using wheelchair
- Patient having a positioning consultation in GARCHES Hospital
Who cannot join
- refusal to participate to the protocol
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Wheelchair Positioning and Pain in Adults Patients With Neuromuscular Disorder
A retrospective study with the patients having a positioning consultation at hospital, between 2009 and 2014. In every neuromuscular disorder, the investigators describe the population seen in consultation, the aim of consultation, the postural problem observed in wheelchair, pain when sitting in wheelchair, and pressure ulcer.
Read the detailed description
Postural problem is described with MCPAA (Measure of Postural Control in Sitting Position, created by B. GAGNON, physiotherapist in Quebec) : we look at pelvic obliquity, pelvic rotation, pelvic anteversion or retroversion, trunk slope and rotation, kyphotic or scoliotic posture, neck posture and legs posture. We evaluate if these deformities are soft, moderate or severe, and if they are relievable
- Being tested
- Positioning consultation
- Keywords
- Neuromuscular, Wheelchair, Pain, Bedsore, Trouble postural
- Medical subject headings
- Pain, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning consultationOther
Assessment of pain,bedsores and postural troubles
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular patients | neuromuscular patients using wheelchair Receives: Other: Positioning consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural disorders
Measured: 2h
Secondary outcomes (1)
Number of patient with Pain
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Neuromuscular Disorders Using WheelchairStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches, Association Française contre les Myopathies (AFM), Paris
- Responsible party
- Sponsor
- Investigators
- PELLEGRINI Nadine, MD, Principal investigator, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141724
- Sponsor's protocol ID
- 0946927B
- Status last verified
- Mar 2015
- First submitted
- 13 May 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Wheelchair Positioning and Pain in Adults Patients With Neuromuscular Disorder
- ClinicalTrials.gov ID
- NCT02141724
- Acronym / sponsor ID
- 0946927B
- Keywords
- Neuromuscular, Wheelchair, Pain, Bedsore, Trouble postural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches, Association Française contre les Myopathies (AFM), Paris
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 May 2014 (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.
A retrospective study with the patients having a positioning consultation at hospital, between 2009 and 2014. In every neuromuscular disorder, the investigators describe the population seen in consultation, the aim of consultation, the postural problem observed in wheelchair, pain when sitting in wheelchair, and pressure ulcer.
Detailed description
Postural problem is described with MCPAA (Measure of Postural Control in Sitting Position, created by B. GAGNON, physiotherapist in Quebec) : we look at pelvic obliquity, pelvic rotation, pelvic anteversion or retroversion, trunk slope and rotation, kyphotic or scoliotic posture, neck posture and legs posture. We evaluate if these deformities are soft, moderate or severe, and if they are relievable
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromuscular patients | – | Other: Positioning consultationneuromuscular patients using wheelchair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients with neuromuscular disordres using wheelchair.
Key inclusion criteria (3 listed)
- Adult patient with neuromuscular disorder
- using wheelchair
- Patient having a positioning consultation in GARCHES Hospital
Key exclusion criteria (2 listed)
- refusal to participate to the protocol
- pregnancy
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 |
|---|---|---|
| Positioning consultationAssessment of pain,bedsores and postural troubles | Other | neuromuscular patients |
Primary outcome
Postural disorders
Time frame: 2h
1 secondary outcome
Number of patient with Pain
Time frame: 15 minutes
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 1 Apr 2015.
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.
PELLEGRINI Nadine, MD principal investigator
HOPITAL RAYMOND POINCARE
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 Adult Patients With Neuromuscular Disorders Using Wheelchair, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 2 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 1 Apr 2015. 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 France. 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?
Postural disorders (time frame: 2h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2015.