Actively Recruiting
Feasibility and Interest of the 3D Ephemeris for Temporal Orientation in Alzheimer's: Pilot Study
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-15
20
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In geriatric care, occupational therapists use validated tools to assess abilities and performance, identifying deficiencies and proposing rehabilitation programs. Temporal orientation disorders are common, with studies showing that individuals who make mistakes in identifying time are at higher risk of dementia. Temporal orientation issues typically precede spatial orientation problems in Alzheimer's, especially in hospital settings where environmental cues are lost. Maintaining temporal orientation during hospitalization is crucial. While no effective rehabilitation tool currently exists, a new prototype has been developed to address temporal orientation disorders in Alzheimer's and dementia patients, with plans for further evaluation. Main Objective Evaluate in real-life conditions the effectiveness of an adapted external aid, such as the Ephéméride 3D tool, in improving temporal orientation rehabilitation for individuals with Alzheimer's disease or related dementias in the mild to moderate stages. Secondary Objectives Assess the feasibility of establishing a routine with hospitalized patients. Gather feedback from patients, their families, and healthcare professionals regarding the external aid (usefulness, practicality, and aesthetics) as a prototype. Evaluate the desire to continue using the tool once patients return home. Count the number of ephémérides deemed appropriate based on positive feedback from patients, families, and healthcare professionals. This figure is valuable for the company that may decide to scale up the product development. It will be calculated from the results of the attached questionnaires. Method This is a monocentric pilot observational study with data collection based on the following steps: Day 5 (D5): Initial MMSE by the patient's physician. Prescription of temporal rehabilitation. Day 6 (D6): Obtaining consent from the patient and their caregiver. Days 6 to 10 (D6 to D10): Daily assessment of the patient's knowledge of the season, year, month, day of the month (date), and day of the week without external aid (E3D). Days 11 to 15 (D11 to D15): Daily assessment with external aid (E3D) for the same temporal knowledge. Day 16 (D16): Interim and partial MMSE by the patient's physician. Days 17 to 21 (D17 to D21): Daily assessment without external aid (E3D). Days 22 to 26 (D22 to D26): Daily assessment with external aid (E3D). Day 27 (D27): Final and complete MMSE by the patient's physician. Days 28 to 30 (D28 to D30): Questionnaires for the patient, their caregiver, and healthcare professionals (including the study referent in the hospital). 20 patients will be included over a 1-year and 30-day period. Descriptive statistical analyses will be conducted to document patient characteristics at admission and the evolution of key parameters over time (D0 to D30). Paired statistical tests (T-tests/Chi-square) will be performed to identify significant changes between visit times. Longitudinal analyses using mixed-effects linear regression models will assess trends over time, accounting for correlations between repeated measures and evaluating differences based on the use of external aids. Conclusion This observational study primarily aims to describe the feasibility and benefits of using the Ephéméride 3D tool to support temporal orientation rehabilitation in individuals with mild to moderate dementia.
CONDITIONS
Official Title
Feasibility and Interest of the 3D Ephemeris for Temporal Orientation in Alzheimer's: Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 65 years old or older
- Patient with temporal orientation impairment during the MMSE test
- Patient with an MMSE score above 20 (mild stage) or between 10 and 20 (moderate stage)
- Patient who has not expressed any objection
You will not qualify if you...
- Presence of one or more disruptive behavioral disorders
- Presence of confusion of unknown origin
- Visual blindness
- Inability to read or understand French
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Georges Clemenceau
Champcueil, France, 91750
Actively Recruiting
Research Team
R
REBOURS Gwénaëlle, Occupational therapist
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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