Intellectual DisabilityREHABILITUSNCT04025398
A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability
A study testing Cognitive remediation program in people with Intellectual Disability, run by Hôpital le Vinatier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Cognitive remediation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Vinatier
Lyon, Auvergne-Rhône-Alpes, 69678
DEMILY MD CAROLINE, PH, 0033437915163, caroline.demily@ch-le-vinatier.fr
VIAL VERONIQUE, 0033437915531, veronique.vial@ch-le-vinatier.fr
About this study
Official title: REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders
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.
- Conditions
- Intellectual Disability
- Being tested
- Cognitive remediation program, Control group
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation programBehavioural
Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)
Control groupBehavioural
Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)
| Study group | Role | What they receive |
|---|---|---|
| REHABILITUS | Experimental | 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. Receives: Behavioral: Cognitive remediation program |
| CONTROL GROUP | Active comparator | The control group involves manual activities and research computer information. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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)
Measured: 6 months
Change from baseline in facial emotion recognition task
Facial Emotions Recognition Task (TREF)
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start17 Jun 2020
- Primary completion17 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a study prospective, randomized, multicenter and controlled which compares two groups of people adults: group to remediation Réhabilitus versus group Control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEMILY CAROLINE, MD Ph, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025398
- Sponsor's protocol ID
- 2019-A00179-48
- Acronym
- REHABILITUS
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2019
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders
- ClinicalTrials.gov ID
- NCT04025398
- Acronym / sponsor ID
- REHABILITUS / 2019-A00179-48
- Conditions
- Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 17 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jul 2019 (actual)
- 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It's a study prospective, randomized, multicenter and controlled which compares two groups of people adults: group to remediation Réhabilitus versus group Control.
| Arm | Type | Receives |
|---|---|---|
| REHABILITUS | Experimental | Behavioral: Cognitive remediation programRéhabilitus 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. |
| CONTROL GROUP | Active comparator | Behavioral: Control groupThe control group involves manual activities and research computer information. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Cognitive remediation programComparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2) | Behavioural | REHABILITUS |
| Control groupComparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2) | Behavioural | CONTROL GROUP |
Primary outcome
Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale
Time frame: 6 months
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.
3 secondary outcomes
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
Time frame: 6 months
Change from baseline in facial emotion recognition task
Time frame: 6 months
Change from baseline in attentional functions
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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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.
DEMILY CAROLINE, MD Ph principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation program in people with Intellectual Disability, run by Hôpital le Vinatier 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 6 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DEMILY CAROLINE, MD Ph (+33437915163, caroline.demily@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale (time frame: 6 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 31 Jul 2025.