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Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision) (PLH-Vision)

22. september 2021 opdateret af: Assistance Publique - Hôpitaux de Paris

The main objective of this study is to develop and validate a visio-behavioral scale of visual abilities for subjects with profound multiple intellectual disabilities.

The secondary objectives of the study are:

  • to validate the structure of the scale.
  • to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
  • to evaluate the feasibility of visio-behavioral scale.
  • to evaluate the sensitivity to change.
  • to study the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
  • to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study includes 3 phases:

  • Elaboration of a list of behavioral items by a group of multi-disciplinary expertise (physicians, nurses, caregivers, ophthalmologies, orthoptists) based on their clinical experiences.
  • Development of the scale based on the sample obtained by a prospective multicenter research trial.
  • Validation of the sample obtained by a prospective transversal multicenter study.

This study will be performed in 5 centers in France. The enrollment of patients planned for 24 months targeting 310 patients. The duration of follow-up of the study for each patient will be varied according to the group of patients, il will be 1 day for group 1, 2 weeks for group 2, or 6 months for group 3.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

232

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
    • Var
      • Hyères, Var, Frankrig, 83407
        • Hôpital San Salvadour

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Profound multiple intellectual disabilities patients aged 3 years or older.

Beskrivelse

Inclusion Criteria:

  • Causal brain injury occurred before the age of 3 years.
  • Severe or deep mental retardation as defined by DSM IV.
  • Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders.
  • Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V.
  • Score of Functional Independence Measure < 55.
  • Subject aged ≥3 years (because the visio-behavioral scale is not adapted for children younger than 3 years).
  • Beneficiary of a social protection.
  • Written consent signed by guardian or legal representative, or parents in case of a minor subject.

Exclusion Criteria:

  • Acute intercurrent pathology precluding examinations.
  • Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride.
  • Angle closure glaucoma suspect patient.
  • Patient with severe hypertension.
  • Short life expectancy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group 1
The duration of follow-up of group 1 in the study is 1 day.
Adfærdsmæssigt: Visual-behavioral Scale at day 1
To perform the classification with the scale by caregiver.
Adfærdsmæssigt: Test-retest at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end of 2 weeks
Adfærdsmæssigt: Test at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.
Group 2
The duration of follow-up of group 2 in the study is 2 weeks.
Adfærdsmæssigt: Test-retest at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end of 2 weeks
Adfærdsmæssigt: Test at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.
Group 3
The duration of follow-up of group 3 in the study is 6 months.
Adfærdsmæssigt: Test at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Concordance of classification
Tidsramme: throughout the study: 31 months
Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.
throughout the study: 31 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Structure of the scale
Tidsramme: throughout the study: 31 months
Statistical analysis to validate the structure of the scale.
throughout the study: 31 months
Reproducibility of scale
Tidsramme: throughout the study: 31 months
Statistical analysis to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
throughout the study: 31 months
Feasibility of visio-behavioral scale
Tidsramme: throughout the study: 31 months

Statistical analysis to evaluate by the proportion of patients who have the complet examination, the average of time to all examens, the tolerance data.

feasibility of visio-behavioral scale.
throughout the study: 31 months
Sensitivity to change
Tidsramme: throughout the study: 31 months
Statistical analysis to evaluate the sensitivity to change.
throughout the study: 31 months
Uniformity of use of the scale
Tidsramme: throughout the study: 31 months
Statistical analysis to assess the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
throughout the study: 31 months
Prevalence of the visual disorder
Tidsramme: throughout the study: 31 months
Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
throughout the study: 31 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Efterforskere

  • Ledende efterforsker: Marie-Christine ROUSSEAU, MD, AP-HP, Hôpital San Salvadour, 83407 Hyères
  • Studiestol: Soizic CHARBONNIER, Orthoptist, Cabinet du Lycée

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. juli 2017

Primær færdiggørelse (Faktiske)

13. april 2021

Studieafslutning (Faktiske)

13. april 2021

Datoer for studieregistrering

Først indsendt

12. december 2016

Først indsendt, der opfyldte QC-kriterier

31. januar 2017

Først opslået (Skøn)

2. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P140712
  • RCB: 2016-A00278-43 (Anden identifikator: ANSM)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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Sponsor / samarbejdspartnere

Placeringer

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