Profound Multiple Intellectual DisabilitiesPLH-VisionNCT03040609
Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
An observational study of Profound Multiple Intellectual Disabilities, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Profound Multiple Intellectual Disabilities
- What is being tested?
- Visual-behavioral Scale at day 1, Test-retest at the end of 2 weeks and Test at 6 months
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2017to 13 Apr 2021
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Profound multiple intellectual disabilities patients aged 3 years or older.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Visual-behavioral Scale at day 1, Test-retest at the end of 2 weeks, Test at 6 months
- Keywords
- Profound Multiple Intellectual Disabilities, Visual-Behavioral Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual-behavioral Scale at day 1Behavioural
To perform the classification with the scale by caregiver.
Test-retest at the end of 2 weeksBehavioural
To perform the classification with the scale by orthoptist at the end of 2 weeks
Test at 6 monthsBehavioural
To perform the classification with the scale by orthoptist at the end 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The duration of follow-up of group 1 in the study is 1 day. Receives: Behavioral: Visual-behavioral Scale at day 1; Behavioral: Test-retest at the end of 2 weeks; Behavioral: Test at 6 months | |
| Group 2 | The duration of follow-up of group 2 in the study is 2 weeks. Receives: Behavioral: Test-retest at the end of 2 weeks; Behavioral: Test at 6 months | |
| Group 3 | The duration of follow-up of group 3 in the study is 6 months. Receives: Behavioral: Test at 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of classification
Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.
Measured: throughout the study: 31 months
Secondary outcomes (6)
Structure of the scale
Statistical analysis to validate the structure of the scale.
Measured: throughout the study: 31 months
Reproducibility of scale
Statistical analysis to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
Measured: throughout the study: 31 months
Feasibility of visio-behavioral scale
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.
Measured: throughout the study: 31 months
Sensitivity to change
Statistical analysis to evaluate the sensitivity to change.
Measured: throughout the study: 31 months
Uniformity of use of the scale
Statistical analysis to assess the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
Measured: throughout the study: 31 months
Prevalence of the visual disorder
Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
Measured: throughout the study: 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start20 Jul 2017
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Profound Multiple Intellectual DisabilitiesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine ROUSSEAU, MD, Principal investigator, AP-HP, Hôpital San Salvadour, 83407 HyèresSoizic CHARBONNIER, Orthoptist, Study chair, Cabinet du Lycée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040609
- Sponsor's protocol ID
- P140712
- Other IDs
- RCB: 2016-A00278-43
- Acronym
- PLH-Vision
- Status last verified
- Feb 2021
- First submitted
- 12 Dec 2016
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
- ClinicalTrials.gov ID
- NCT03040609
- Acronym / sponsor ID
- PLH-Vision / P140712
- Keywords
- Profound Multiple Intellectual Disabilities, Visual-Behavioral Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 2 Feb 2017 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Visual-behavioral Scale at day 1, Behavioral: Test-retest at the end of 2 weeks, Behavioral: Test at 6 monthsThe duration of follow-up of group 1 in the study is 1 day. |
| Group 2 | – | Behavioral: Test-retest at the end of 2 weeks, Behavioral: Test at 6 monthsThe duration of follow-up of group 2 in the study is 2 weeks. |
| Group 3 | – | Behavioral: Test at 6 monthsThe duration of follow-up of group 3 in the study is 6 months. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Profound multiple intellectual disabilities patients aged 3 years or older.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual-behavioral Scale at day 1To perform the classification with the scale by caregiver. | Behavioural | Group 1 |
| Test-retest at the end of 2 weeksTo perform the classification with the scale by orthoptist at the end of 2 weeks | Behavioural | Group 1, Group 2 |
| Test at 6 monthsTo perform the classification with the scale by orthoptist at the end 6 months. | Behavioural | Group 1, Group 2, Group 3 |
Primary outcome
Concordance of classification
Time frame: throughout the study: 31 months
Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.
6 secondary outcomes
Structure of the scale
Time frame: throughout the study: 31 months
Reproducibility of scale
Time frame: throughout the study: 31 months
Feasibility of visio-behavioral scale
Time frame: throughout the study: 31 months
Sensitivity to change
Time frame: throughout the study: 31 months
Uniformity of use of the scale
Time frame: throughout the study: 31 months
Prevalence of the visual disorder
Time frame: throughout the study: 31 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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.
Marie-Christine ROUSSEAU, MD principal investigator
AP-HP, Hôpital San Salvadour, 83407 Hyères
Soizic CHARBONNIER, Orthoptist study chair
Cabinet du Lycée
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Profound Multiple Intellectual Disabilities, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 23 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of classification (time frame: throughout the study: 31 months). 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 23 Sep 2021.