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NCT Number: NCT06781645

Evaluation of the Effects of Serious Cognitive Games on a Digital Tactile Table for Elderly People with Alzheimer's Disease or Related Disorders

Alzheimer's disease and related disorders are chronic, progressive diseases that have a major impact on the lives of sufferers and their families. They lead to a decline in cognitive function and are associated with a loss of independence and quality of life for sufferers. The loss of autonomy associated with major cognitive disorders can lead to feelings of worthlessness and loss of self-esteem. People may feel sad, depressed and, above all, very anxious. When this anxiety is linked to relationships with others, it can become major social anxiety, which aggravates the negative feelings and contributes to the deleterious progression of the neurodegenerative disease. Feelings of low self-esteem and/or the anxiety that accompanies them cannot be treated solely by long-term psychotropic drugs, as these can worsen the disorders through iatrogenesis. In this context, non-drug approaches can be seen as an essential complement.

Cognition-based therapies, including cognitive stimulation, are based on a neuroeducational approach that can be deployed at different stages of the disease, either individually or in groups. Other patient-centred cognitive stimulation techniques have also been developed. In recent years, research has focused on serious digital games, which seem to combine rehabilitation possibilities in a playful form, making it easier for patients to adhere to them. They can also be used to work on motor skills, spatial reference, reflexes and speed and potentially improve verbal and non-verbal learning. Several recent meta-analyses have shown that brain games are an innovative and potentially effective approach to cognitive training for elderly people with cognitive disorders.

Based on the existing literature, experimenting with a serious digital cognitive game could potentially produce beneficial results by improving parameters such as self-esteem and anxiety in patients with early or moderate Alzheimer's disease or a related illness. As part of their weekly cognitive stimulation programme at the day hospital, they plan to use the interactive digital table 'Le Village' ©, which can be used to offer fun exercises on working memory, semantic memory, explicit memory and sensory memory, with game objectives focusing on reaction, reminiscence and dexterity. The digital table simulates a village, allowing 6 people to play simultaneously and interact. This digital table can be used for individual or group sessions.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Person aged ≥ 65 years
  • A person with Alzheimer's disease or a related disorder established by a full medical diagnosis according to DSM-5 criteria, at a mild to moderate stage defined by a Mini-Mental State (MMSE) ≥ 15/30
  • A person who regularly attends the day hospital at Charles Foix Hospital Persons able to give their consent to take part in the study

Exclusion criteria

  • Person with severe neurocognitive disorders (MMSE < 15/30)
  • Person refusing to participate

Treatment and study plan

The system involves a digital table with a tactile and interactive surface, providing several play areas. It simulates a village and offers different types of serious cognitive games: semantic memory

Other

Each patient included will benefit from a series of 6 sessions of cognitive stimulation with the interactive digital table of cognitive games 'Le Village de Verdurable'©, and a series of 6 sessions of 'classic' weekly cognitive stimulation at the rate of one session per week, i.e. without the digital table and using the methods of cognitive stimulation normally used in the department. The weekly session used as a comparator in the usual condition will be a session based on concentration and attention with target finding or error finding. The order in which these 2 series of 6 sessions will be carried out will be defined randomly (by drawing lots) before the start of the trial.

Primary outcomes

  1. Rosenberg Self-Esteem Scale

    Time frame: about 3 months

    40-point scale: the higher the score, the higher the self-esteem, and the lower the score, the lower the self-esteem.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: about 3 months

    This 14-item scale gives two scores for anxiety and depression, each out of 21 points. A score of more than 11 indicates anxiety or depression.

  2. the Occupational Therapy Engagement Scale

    Time frame: about 3 months

    This 12-item scale can range from 0 to 36 points. The lower the score, the more difficult it is for the person to engage in therapeutic activities, and vice versa.

  3. scale for rating the person being helped during an interaction with a caregiver

    Time frame: about 3 months

    A 10-item scale, with scores ranging from 10 to 20. The lower the score, the less engaged in the activity, and vice versa.

Other outcomes

  1. the French version of the System Usability Scale

    Time frame: about 1 month

    scale consisting of 10 questions. The score is calculated as a percentage, and the higher the score, the more positive the user experience.

Study contacts

Contact information is provided by the study sponsor or research team.

Joël Belmin, Professor

CONTACT

[email protected]

00331 49 59 45 65

Sylvie Pariel, Doctor

CONTACT

[email protected]

00 331 49 59 43 76

Sponsors and collaborators

Lead sponsor

RIVAGES

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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