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RecruitingNCT04025398REHABILITUSUpdated Jul 31, 2025

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

An interventional study of Cognitive remediation program and Control group in Intellectual Disability, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2020; still recruiting 6 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Intellectual Disability
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In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's planned enrollment of 116 is above the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
116 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Cognitive remediation program

  • Active comparator
    CONTROL GROUP

    The control group involves manual activities and research computer information.

    Behavioral: Control group

Interventions

  • BehavioralCognitive remediation program

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

  • BehavioralControl group

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

06

What researchers measure

Primary outcomes

  1. Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale

    Aberrant Behavior Checklist scale (ABC) The ABC scale \[20\] is a 58-item scale for people close to the autistic person. Scores are distributed in five subscale: irritability, agitation, crying; of lethargy and social withdrawal; stereotyped behaviors; hyperactivity; inappropriate language.

    Time frame: 6 months

Secondary outcomes

  1. This measure is repeated at the end of the intervention to highlight the impact of the " Cognitus and Me " program, and 6 months later to investigate the possible long-lasting effects of the benefits

    ABC scale (Irritability and social withdrawal)

    Time frame: 6 months

  2. Change from baseline in facial emotion recognition task

    Facial Emotions Recognition Task (TREF)

    Time frame: 6 months

  3. Change from baseline in attentional functions

    Sustained Attention on LEITER-3 Battery Attention scales and memory - forward memory, reverse memory, sustained attention, divided attention, non-verbal stroop.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04025398
Lead sponsor
Hôpital le Vinatier
Responsible party
Sponsor
First posted
Jul 18, 2019
Start date
Jun 17, 2020
Primary completion
Jun 17, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 31, 2025

Study contacts

DEMILY CAROLINE, MD Ph
Contact
caroline.demily@ch-le-vinatier.fr
+33437915163
BABINET MARIE-NOELLE
Contact
marie-noelle.babinet@ch-le-vinatier.fr
+33437915163
DEMILY CAROLINE, MD Ph
principal investigator · Centre Hospitalier le Vinatier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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