Wheelchair Positioning and Pain in Neuromuscular Patients | NCT02141724

Studies
Wheelchair Positioning and Pain in Neuromuscular Patients

NCT02141724

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Apr 1, 2015Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Adult Patients With Neuromuscular Disorders Using Wheelchair

Interventions

Positioning consultation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

May 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 13, 2014

First Submission Date that Met QC Criteria

May 15, 2014

First Posted Date

May 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2015

Last Update Posted Date

Apr 1, 2015Estimated

Name	Class
Fondation Garches	OTHER
Association Française contre les Myopathies (AFM), Paris	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neuromuscular patients		neuromuscular patients using wheelchair	Other: Positioning consultation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Positioning consultation	Other	Assessment of pain,bedsores and postural troubles	neuromuscular patients

Measure	Description	Time Frame
Postural disorders		2h

Measure	Description	Time Frame
Number of patient with Pain		15 minutes

Measure	Description	Time Frame
Bedsores		15 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient with neuromuscular disorder
using wheelchair
Patient having a positioning consultation in GARCHES Hospital

Exclusion Criteria:

refusal to participate to the protocol
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults patients with neuromuscular disordres using wheelchair.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PELLEGRINI Nadine, MD	HOPITAL RAYMOND POINCARE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Raymond Poincare		Garches	Garches	92380	France

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012883	Skin Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided