Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision) (PLH-Vision)
22 september 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
232
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Var
-
Hyères, Var, Frankrike, 83407
- Hôpital San Salvadour
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Profound multiple intellectual disabilities patients aged 3 years or older.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Group 1
The duration of follow-up of group 1 in the study is 1 day.
|
To perform the classification with the scale by caregiver.
To perform the classification with the scale by orthoptist at the end of 2 weeks
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.
|
To perform the classification with the scale by orthoptist at the end of 2 weeks
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.
|
To perform the classification with the scale by orthoptist at the end 6 months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Concordance of classification
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Structure of the scale
Tidsram: throughout the study: 31 months
|
Statistical analysis to validate the structure of the scale.
|
throughout the study: 31 months
|
|
Reproducibility of scale
Tidsram: 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
Tidsram: 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
Tidsram: throughout the study: 31 months
|
Statistical analysis to evaluate the sensitivity to change.
|
throughout the study: 31 months
|
|
Uniformity of use of the scale
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Marie-Christine ROUSSEAU, MD, AP-HP, Hôpital San Salvadour, 83407 Hyères
- Studiestol: Soizic CHARBONNIER, Orthoptist, Cabinet du Lycée
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 juli 2017
Primärt slutförande (Faktisk)
13 april 2021
Avslutad studie (Faktisk)
13 april 2021
Studieregistreringsdatum
Först inskickad
12 december 2016
Först inskickad som uppfyllde QC-kriterierna
31 januari 2017
Första postat (Uppskatta)
2 februari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 september 2021
Senast verifierad
1 februari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P140712
- RCB: 2016-A00278-43 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
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