Motor DisordersDIS-HANDINCT02720731
Care-related Pain and Discomfort in People With Motor Disorder
An observational study of Motor Disorders and Pain, run by University Hospital, Brest at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Motor Disorders, Pain
- How many people
- 600 participants
- Where
- 10 sitesFrance
- Study dates
- Apr 2016to Nov 2017
- 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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children and adults with motor disorders admitted in medical institutions
Who may be able to join
- motor disorder
- institutionalized
Who cannot join
- chronical pain
Trial locations and contacts
10 sites in 1 country.
Amandine DUBOIS contact
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Centre Creac'h Ar Roual
Dirinon, 29460
Françoise ROGE
- Recruiting
IME section polyhandicapes Kerlaouen
Guipavas, 29490
Françoise ROGE
- Not yet recruiting
SEAPH-IME Kerveguen
Plabennec, 29860
Sylvain Brochard
- Not yet recruiting
IEM Plerin
Plérin, 22193
Bruno Fagnet
- Not yet recruiting
IEM Ar Men
Ploemeur, 56270
Mathilde Creusat
- Recruiting
Centre de Rééducation fonctionnelle de Kerpape
Ploemeur, 56275
Hélène Le Tallec
- Not yet recruiting
CHRU de Rennes
Rennes, 35000
Hélène Rauscent
- Recruiting
Fondation Ildys site de Perhardy
Roscoff, 29684
Sylvaine Rumeur
- Not yet recruiting
Centre Rééducation Trestel
Trévou-Tréguignec, 22660
Laurent Jesequel
- Not yet recruiting
EEAP Maison de L'estran
Trévou-Tréguignec, 22660
Dr Darnois
About this study
Official title: Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments
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.
- Conditions
- Motor Disorders, Pain
- Medical subject headings
- Motor Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children | aged from 1 to 18 years with motor disorder | |
| adults | aged from 18 to 80 years with motor disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale
Measured: 5 days
Secondary outcomes (1)
Pain related to care-activities assessed with the Visual Analog Scale (VAS).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Fondation Motrice, Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- sylvain BROCHARD, Study director, Univesrity Hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720731
- Sponsor's protocol ID
- DIS-HANDI (RB 14.188)
- Acronym
- DIS-HANDI
- Status last verified
- Jul 2016
- First submitted
- 10 Mar 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments
- ClinicalTrials.gov ID
- NCT02720731
- Acronym / sponsor ID
- DIS-HANDI / DIS-HANDI (RB 14.188)
- Conditions
- Motor Disorders, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Fondation de France, Fondation Motrice, Fondation Apicil
- Study start
- Apr 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 28 Mar 2016 (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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children | – | –aged from 1 to 18 years with motor disorder |
| adults | – | –aged from 18 to 80 years with motor disorder |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children and adults with motor disorders admitted in medical institutions
Key inclusion criteria (2 listed)
- motor disorder
- institutionalized
Key exclusion criteria (1 listed)
- chronical pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale
Time frame: 5 days
1 secondary outcome
Pain related to care-activities assessed with the Visual Analog Scale (VAS).
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
Amandine DUBOIS contact
sylvain BROCHARD study director
Univesrity Hospital of Brest
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Disorders and Pain, run by University Hospital, Brest at 10 sites 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 2 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain BROCHARD (02-98-22-26-88, sylvain.brochard@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale (time frame: 5 days). 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 12 Jul 2016.