Care-related Pain and Discomfort in People With Motor Disorder

NCT ID: NCT02720731

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Motor Disorders Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

children

aged from 1 to 18 years with motor disorder

No interventions assigned to this group

adults

aged from 18 to 80 years with motor disorder

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* motor disorder
* institutionalized

Exclusion Criteria

* chronical pain
Minimum Eligible Age

1 Year

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation de France

OTHER

Sponsor Role collaborator

Fondation Motrice

OTHER

Sponsor Role collaborator

Fondation Apicil

OTHER

Sponsor Role collaborator

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

sylvain BROCHARD

Role: STUDY_DIRECTOR

Univesrity Hospital of Brest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Creac'h Ar Roual

Dirinon, , France

Site Status RECRUITING

IME section polyhandicapes Kerlaouen

Guipavas, , France

Site Status RECRUITING

SEAPH-IME Kerveguen

Plabennec, , France

Site Status NOT_YET_RECRUITING

IEM Plerin

Plérin, , France

Site Status NOT_YET_RECRUITING

IEM Ar Men

Ploemeur, , France

Site Status NOT_YET_RECRUITING

Centre de Rééducation fonctionnelle de Kerpape

Ploemeur, , France

Site Status RECRUITING

CHRU de Rennes

Rennes, , France

Site Status NOT_YET_RECRUITING

Fondation Ildys site de Perhardy

Roscoff, , France

Site Status RECRUITING

Centre Rééducation Trestel

Trévou-Tréguignec, , France

Site Status NOT_YET_RECRUITING

EEAP Maison de L'estran

Trévou-Tréguignec, , France

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sylvain BROCHARD

Role: CONTACT

02-98-22-26-88

Amandine DUBOIS

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Françoise ROGE

Role: primary

Françoise ROGE

Role: primary

Sylvain Brochard

Role: primary

Bruno Fagnet

Role: primary

Mathilde Creusat

Role: primary

Hélène Le Tallec

Role: primary

Hélène Rauscent

Role: primary

Sylvaine Rumeur

Role: primary

Laurent Jesequel

Role: primary

Dr Darnois

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DIS-HANDI (RB 14.188)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.