Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorCentral Hospital, Nancy, France

About this trial

Difficulty orienting oneself and finding one's way around the environment, also known as "topographical disorientation" (TD) or "spatial disorientation" (SD), is a common and often early symptom of Alzheimer's disease (AD) that affects people's independence and well-being. Being able to identify it is therefore crucial in order to provide appropriate support.

It cannot be assessed using conventional psychometric tests due to its low ecological validity. Several subjective assessment scales have been created to screen for SD "spatial disorientation" and assess its functional and psychological impact. However, none of these scales have been translated and validated in French. As a result, DS is not assessed in routine clinical practice.

Among these scales, the Wayfinding Questionnaire (WQ) explores three dimensions: spatial orientation, distance estimation, and spatial anxiety. This questionnaire has undergone psychometric validation studies in its original Dutch version for a population with mild post-stroke , and norms for the general population have been published.

Our team translated this questionnaire into French (i.e., "Questionnaire d'Orientation Spatiale" (QOS)) and adapted it cross-culturally to preserve the qualities of the measurement. A "Caregiver" version was also created, taking into account the anosognosia known to occur in AD. Primary Objective : Evaluate the psychometric properties of the Spatial Orientation Questionnaire (SOSQ) (i.e., the French translation and adaptation of the Wayfinding Questionnaire) in assessing spatial orientation disorders in patients with Alzheimer's disease, in both its "patient" and "caregiver" versions. Secondary objective : Evaluate the acceptability of the Spatial Orientation Questionnaire (SOC) in its "patient" and "caregiver" versions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Native French speakers

Independent mobility: (minimum mobility range of 3 (i.e., neighborhood) on the LSA-F assessment of the mobility zone scale)

Person affiliated with a social security system or beneficiary of such a system

Individuals who have received complete information about the clinical research organization and have signed their written informed consent

Disqualifiers

Adults subject to legal protection measures (guardianship, curatorship, judicial protection)

Adults unable to give their consent

Persons deprived of their liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1.

Persons capable of giving consent but unable to read French

Trial population

Patients with Alzheimer disease and their caregivers

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire d'Orientation Spatiale (QOS)

    Diagnostic test

    French version of the wayfinding questionnaire

Treatment groups

330 Participants
are divided into 3 treatment groups
Group A: Patients Group1 intervention
Group B: Accompanying persons1 intervention
Group C: Control arm1 intervention

Trial outcomes

Primary outcomes

1

French version of the QOS Score

There are three sub-scores in total : * "Navigation and Orientation" sub-score (sum of items 1, 2, 3, 6, 7, 13, 15, 16, 17, 18, 19) * "Distance estimation" sub-score (sum of items 4, 5, 14) * "Spatial anxiety" subs-core (sum of the reversed scores for items 8, 9, 10, 11, 20, 21, 22, 12) For these three sub-scores, a high score indicates a good level of spatial orientation.

Time frame
Baseline and between 30 and 90 days after baseline for groups A1, A2, A3, B1 and B2

Secondary outcomes

Other outcomes

Sponsors and contacts

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