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ParaparesisEval-PLHNCT02400528

Prospective Cohort Follow-up of French Patients With Profound and Multiple Disabilities: Healthcare Pathways and Quality of Life Among Patients and Their Families

A study testing quality of life questionnaires in people with Paraparesis and Tetraparesis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The studies conducted so far concerning the medical and paramedical cares provided to patients with profound and multiple disabilities (PMD) often show important limitations: samples are too small or very heterogeneous, generally constituted of children only; studies are mainly cross-sectional and retrospective… Read more about this study

Who is it for?
Ages 3 years and older
Conditions the study is for
Paraparesis, Tetraparesis, Hemiparesis
What is being tested?
quality of life questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteFrance
Study dates
Feb 2015to Feb 2019
Phase
Interventional
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 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • age > 3 years old,
  • patient with health insurance,
  • causal brain injury before the age of 3,
  • Intellectual Quotient < 40 or not assessable,
  • motor disability: paraparesis, tetraparesis, hemiparesis, ataxia, neuromuscular disorders, or extrapyramidal motor disorders,
  • score at the Gross Motor Function Classification System > 3,
  • score at the Functional Independence Measure < 55.

Who cannot join

  • Subject declaring benefit "psychotropic treatment which" significantly alter the reasoning, discernment or judgment.

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting

  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13354

    Urielle DESALBRES, Director, 04.91.38.27.47, drci@ap-hm.fr

    Pascal AUQUIER, Professor

    Recruiting

Other trials in France

About this study

The studies conducted so far concerning the medical and paramedical cares provided to patients with profound and multiple disabilities (PMD) often show important limitations: samples are too small or very heterogeneous, generally constituted of children only; studies are mainly cross-sectional and retrospective, focusing on very specific issues instead of assessing health and quality of life from a more global perspective… So far, the investigators found no published data from a prospective cohort study involving a representative sample of patients with PMD. The present project aims to set up such a cohort so as to describe for the first time the natural history of French patients with PMD as well as the cares they receive at home or within the different dedicated structures in France. This cohort will also make it possible to identify the factors responsible for differences in the cares patients are provided, the consequences of these differences on their health and their quality of life (and those of their relatives) as well as the evolutions of these data over time. It will then allow for assessing the effectiveness of the French healthcare system to care for patients with PMD as well as building a frame of reference regarding the best cares to provide to these patients.

The primary goal of this study is to identify the determinants of health among patients with PMD.

Being tested
quality of life questionnaires
Medical subject headings
Paraparesis, Quadriplegia, Paresis, Ataxia, Neuromuscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quality of life questionnairesBehavioural

Study groups in NCT02400528
Study groupRoleWhat they receive
Patients With Profound and Multiple DisabilitiesOtherNot described
Receives: Behavioral: quality of life questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregivers quality of life

    Assessment of quality of life from questionnaires,WHOQOL-Bref, Brief-COPE

    • Brief-COPE

    Measured: 36 months

Secondary outcomes (2)

  1. emotional distress and subjective burden of natural caregivers,

    Assessment of quality of life from questionnaires,WHOQOL-Bref

    • Brief-COPE
    • CRA

    Measured: 36 months

  2. burnout of institutional caregivers

    Assessment of quality of life from questionnaires,WHOQOL-Bref

    • Brief-COPE
    • MBI

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionFeb 2018 (estimated)
  4. Study completionFeb 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02400528
Sponsor's protocol ID
2014-21
Other IDs
RCAPHM14_0082, 2014-A00953-44
Acronym
Eval-PLH
Status last verified
Feb 2015
First submitted
4 Feb 2015
Last updated
27 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Rousseau MC, Anzola AB, El Ouazzani H, Hamouda I, Del Duca S, Fouladvand M, Loukkal S, de Villemeur TB, Auquier P, Baumstarck K; EVAL-PLH Group. Health and Care Characteristics of Ageing Adults With Profound Intellectual and Multiple Disabilities Living in French Facilities. J Appl Res Intellect Disabil. 2026 Nov;39(6):e70324. doi: 10.1111/jar.70324.

    PubMed 42947490

  • El Ouazzani H, Rousseau MC, Beltran-Anzola A, Del Duca S, Hamouda I, Billette de Villemeur T, Auquier P, Baumstarck K. Burnout among French healthcare workers caring for individuals with profound intellectual and multiple disabilities/polyhandicap: a complementary cross-sectional and longitudinal study. Front Public Health. 2026 Sep 28;14:1906622. doi: 10.3389/fpubh.2026.1906622. eCollection 2026.

    PubMed 42865935

  • Baumstarck K, Loukkal S, El Ouazzani H, Del Duca S, Beltran A, Hamouda I, Rousseau MC. Care trajectories in children with profound intellectual and multiple disabilities/polyhandicap: a cross-sectional study of the French National Cohort. Front Public Health. 2026 Jul 3;14:1873749. doi: 10.3389/fpubh.2026.1873749. eCollection 2026.

    PubMed 42491094

  • Rousseau MC, Del-Duca S, Beltran A, Ouazzani HE, Hamouda I, de Villemeur TB, Auquier P; Eval-PLH Group; Baumstarck K. Young adults with PIMD Polyhandicap in pediatric settings a situation more complex than problematic. Sci Rep. 2026 May 26;16(1):23990. doi: 10.1038/s41598-026-51457-3.

    PubMed 42191771

  • Baumstarck K, Hamouda I, Iline N, El Ouazzani H, Fouladvand M, Loukkal S, Beltran Anzola A, Del Duca S, Rousseau MC; EVAL-PLH Group. Quality of life among individuals with profound intellectual and multiple disabilities: crossed perspectives of institutional caregivers and parents. Health Qual Life Outcomes. 2025 Oct 6;23(1):96. doi: 10.1186/s12955-025-02434-3.

    PubMed 41053826

  • Baumstarck K, Del Duca S, El Ouazzani H, Hamouda I, Beltran Anzola A, Aim MA, Rousseau MC. Increased Life Expectancy of People With Profound Intellectual and Multiple Disabilities: What Does It Change for Parents? J Appl Res Intellect Disabil. 2025 Jan;38(1):e70018. doi: 10.1111/jar.70018.

    PubMed 39934966

  • Rousseau MC, Beltran A, Hamouda I, Aim MA, Felce A, Lind K, Khaldi N, El Ouazzani H, Auquier P, de Villemeur TB, Baumstarck K. Impact of caring for patients with polyhandicap on institutional health care workers' quality of life: a cross-sectional and longitudinal evaluation. Front Public Health. 2024 Oct 18;12:1427289. doi: 10.3389/fpubh.2024.1427289. eCollection 2024.

    PubMed 39494083

  • Baumstarck K, Hamouda I, Aim MA, Anzola AB, Khaldi-Cherif S, Felce A, Maincent K, Lind K, Auquier P, Billette de Villemeur T, Rousseau MC; and the EVAL-P. L. H. Group. Health care management adequacy among French persons with severe profound intellectual and multiple disabilities: a longitudinal study. BMC Health Serv Res. 2024 Jan 18;24(1):99. doi: 10.1186/s12913-024-10552-9.

    PubMed 38238747

  • Hamouda I, Rousseau MC, Beltran Anzola A, Aim MA, de Villemeur TB, Auquier P, Baumstarck K; EVAL-PLH group. The French EVAL-PLH cohort of persons with polyhandicap. Sci Rep. 2022 Jul 22;12(1):12512. doi: 10.1038/s41598-022-16596-3.

    PubMed 35869128

  • Rousseau MC, Baumstarck K, Valkov M, Felce A, Brisse C, Khaldi-Cherif S, Loundou A, Auquier P, Billette de Villemeur T; French Polyhandicap Group. Impact of severe polyhandicap cared for at home on French informal caregivers' burden: a cross-sectional study. BMJ Open. 2020 Feb 2;10(1):e032257. doi: 10.1136/bmjopen-2019-032257.

    PubMed 32014871

  • Rousseau MC, Billette de Villemeur T, Khaldi-Cherif S, Brisse C, Felce A, Baumstarck K, Auquier P; French Polyhandicap Group. Adequacy of care management of patients with polyhandicap in the French health system: A study of 782 patients. PLoS One. 2018 Jul 6;13(7):e0199986. doi: 10.1371/journal.pone.0199986. eCollection 2018.

    PubMed 29979745

Questions about this trial

What is this clinical trial studying?

A study testing quality of life questionnaires in people with Paraparesis and Tetraparesis, run by Assistance Publique Hopitaux De Marseille 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 7 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 27 Mar 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregivers quality of life (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02400528, which also lists 11 linked publications.

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 27 Mar 2015.

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