A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability

NCT ID: NCT04025398

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2026-12-31

Brief Summary

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Adults with intellectual disabilities have great difficulty in adapting to social situations and relationships. Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved. Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are adults with intellectual disabilities manner in their daily functioning

Detailed Description

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Réhabilitus is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among adults with intellectual disabilities. The main objective is to validate the effectiveness of Réhabilitus program on behavioral disorders in adults with intellectual disabilities without autism spectrum disorder associated.

Conditions

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Intellectual Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It's a study prospective, randomized, multicenter and controlled which compares two groups of people adults: group to remediation Réhabilitus versus group Control.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blindness of the psychologist for the secondary judgment criteria.

Study Groups

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REHABILITUS

Réhabilitus is a cognitive remediation program focused on the functions of attention and visuospatial that is to say that can move in space, to perceive objects of our environment and organize them, to mentally imagine a physically absent operation object very involved in social behavior, in order to limit the presence of behavioral disorders among adults with intellectual disabilities.

Group Type EXPERIMENTAL

Cognitive remediation program

Intervention Type BEHAVIORAL

Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)

CONTROL GROUP

The control group involves manual activities and research computer information.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)

Interventions

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Cognitive remediation program

Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)

Intervention Type BEHAVIORAL

Control group

Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 to 45 inclusive;
* Behavioral disorders corresponding to a total score on the ABC scale \> 15
* Presence of a family caregiver (parent, friend) or professional (reeducator, professional of the medico-social sector) stakeholder of the project;
* Diagnosis of mild to moderate intellectual disability (assessed by WAIS-IV battery and VABS-II less than 3 years ago;
* French or secondary mother tongue;
* Psychoactive treatment unchanged during the month prior to inclusion;
* Adult or legal representative who has given written and informed consent to participate in the study. By default, the adult's oral agreement will be collected (as well as the written consent of the legal representative);
* Affiliation to the social security scheme or beneficiary of such a scheme.

Exclusion Criteria

* Neurological disorders of vascular, infectious or neurodegenerative origin;
* Taking medications for general medical purposes with a neurological or psychiatric impact (eg corticosteroids);
* Simultaneous participation in any other cognitive remediation program targeting attentional, visuospatial and social cognition;
* Refusal of participation of the person and/or his/her legal representative;
* Not family or professional caregiver;
* Presence of Autistic Spectrum Disorders (evaluated by ADOS and ADI if necessary according to the assessment of the investigator)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DEMILY CAROLINE, MD Ph

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Vinatier

Locations

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Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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DEMILY CAROLINE, MD Ph

Role: CONTACT

+33437915163

BABINET MARIE-NOELLE

Role: CONTACT

+33437915163

Facility Contacts

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DEMILY MD CAROLINE, PH

Role: primary

0033437915163

VIAL VERONIQUE

Role: backup

0033437915531

Other Identifiers

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2019-A00179-48

Identifier Type: -

Identifier Source: org_study_id

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