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Status unknownNCT02720731DIS-HANDIUpdated Jul 12, 2016

Care-related Pain and Discomfort in People With Motor Disorder

An observational study in Motor Disorders and Pain, sponsored by University Hospital, Brest. Status unknown at 10 sites in France. Open to participants aged 1 Year to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-12.

Sponsored by University Hospital, Brest · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
600
Ages
1 Year to 80 Years
Sex
All
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Study summary

The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up.

All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS).

Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.

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Conditions studied

  • Motor Disorders
  • Pain

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03

In context

Motor Disorders

78 studies on the registry are indexed under Motor Disorders; 26 are open to participants now.

This study's planned enrollment of 600 is above the median of 70 across 23 observational studies indexed under Motor Disorders.

Browse Motor Disorders studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

children and adults with motor disorders admitted in medical institutions

Inclusion criteria

  • motor disorder
  • institutionalized

Exclusion criteria

Exclusion Criteria:

  • chronical pain
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • children

    aged from 1 to 18 years with motor disorder

  • adults

    aged from 18 to 80 years with motor disorder

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What researchers measure

Primary outcomes

  1. Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale

    Time frame: 5 days

Secondary outcomes

  1. Pain related to care-activities assessed with the Visual Analog Scale (VAS).

    Time frame: 5 days

07

Study locations

4 of 10 sites recruiting
  • Centre Creac'h Ar Roual
    Dirinon, 29460, France
    • Françoise ROGE · Contact
    Recruiting
  • IME section polyhandicapes Kerlaouen
    Guipavas, 29490, France
    • Françoise ROGE · Contact
    Recruiting
  • SEAPH-IME Kerveguen
    Plabennec, 29860, France
    • Sylvain Brochard · Contact
    Not yet recruiting
  • IEM Plerin
    Plerin cedex, 22193, France
    • Bruno Fagnet · Contact
    Not yet recruiting
  • IEM Ar Men
    Ploemeur, 56270, France
    • Mathilde Creusat · Contact
    Not yet recruiting
  • Centre de Rééducation fonctionnelle de Kerpape
    Ploemeur, 56275, France
    • Hélène Le Tallec · Contact
    Recruiting
  • CHRU de Rennes
    Rennes, 35000, France
    • Hélène Rauscent · Contact
    Not yet recruiting
  • Fondation Ildys site de Perhardy
    Roscoff Cedex, 29684, France
    • Sylvaine Rumeur · Contact
    Recruiting
  • Centre Rééducation Trestel
    Trevou Treguignec, 22660, France
    • Laurent Jesequel · Contact
    Not yet recruiting
  • EEAP Maison de L'estran
    Trevou Treguignec, 22660, France
    • Dr Darnois · Contact
    Not yet recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02720731
Lead sponsor
University Hospital, Brest
Collaborators
Fondation de France, Fondation Motrice, Fondation Apicil
Responsible party
Sponsor
First posted
Mar 28, 2016
Start date
Apr 2016
Primary completion
Nov 2017 (estimated)
Completion
Nov 2017 (estimated)
Last update
Jul 12, 2016

Study contacts

Sylvain BROCHARD
Contact
sylvain.brochard@chu-brest.fr
02-98-22-26-88
Amandine DUBOIS
Contact
amandine.dubois@univ-brest.fr
sylvain BROCHARD
study director · Univesrity Hospital of Brest

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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