Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease

NCT07616063 | Not Yet Recruiting DMC

• 2 other identifiers: 2019PI271N°ID-RCB : 2025-A00441-48
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer s Disease; Spatial Orientation

Keywords

Alzheimer s disease

Outcome Measures

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.

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

Study Arms (3)

Patients Group

Patients with Alzheimer disease

Diagnostic Test: Questionnaire d'Orientation Spatiale (QOS)

Accompanying persons

Relatives (friends or family) of patients with alzheimer disease

Diagnostic Test: Questionnaire d'Orientation Spatiale (QOS)

Control arm

Healthy participants

Diagnostic Test: Questionnaire d'Orientation Spatiale (QOS)

Interventions

Questionnaire d'Orientation Spatiale (QOS) DIAGNOSTIC_TEST

French version of the wayfinding questionnaire

Accompanying persons; Control arm; Patients Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Alzheimer disease and their caregivers

You may qualify if:

• For all subjects :
• 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
• Patients (Subgroup A1) and healthy control subjects (Group C):
• Individuals who have received complete information about the clinical research organization and have signed their written informed consent
• Patients (Subgroups A2 and A3) and Companions (Group B) Individuals who have received complete information about the clinical research and have agreed to participate
• Patients (group A):
• Aged 55 to 85
• Diagnosis of probable Alzheimer's disease (NINCDR-ADRDA diagnostic criteria)
• Score of 4 or less on the Hachinski Ischemic Scale
• Score of 20 or higher on the Folstein MMSE (Mini Mental State Examination)
• In the case of specific treatment for Alzheimer's disease (anticholinesterase and memantine treatments), treatment stability for \> 15 days
• Able to walk independently, i.e., without assistance, whether human or technical, except for a simple cane
• Caregivers (group B):

You may not qualify if:

• For all subjects:
• 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
• Persons capable of giving consent but unable to write
• One of the members of the patient/caregiver dyad refusing to participate in the study.
• Patients (subgroup A1) and healthy control subjects (group C):
• Sensory or phasic deficit interfering with the task.
• History of moderate or severe head trauma (with loss of consciousness).
• Change in psychotropic treatment less than 48 hours before the tests
• Chronic alcoholism
• Severe depression (score greater than or equal to 10 on the GDS-15 Geriatric Depression Scale)
• Presence of other clinically significant psychiatric or neurological conditions (except Alzheimer disease for case subjects)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU (Centre Hospitalier Régionale Universitaire) Nancy

Nancy, 54500, France

Location

Related Publications (8)

• Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.

  PMID: 8263569 BACKGROUND

• Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015 Apr;68(4):435-41. doi: 10.1016/j.jclinepi.2014.11.021. Epub 2014 Dec 17.

  PMID: 25698408 BACKGROUND

• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

  PMID: 11124735 BACKGROUND

• van der Ham IJM, Claessen MHG. A clinical guide to assessment of navigation impairment: Standardized subjective and objective instruments and normative data. J Clin Exp Neuropsychol. 2022 Sep;44(7):487-498. doi: 10.1080/13803395.2022.2123895. Epub 2022 Sep 21.

  PMID: 36129157 BACKGROUND

• de Rooij NK, Claessen MHG, van der Ham IJM, Post MWM, Visser-Meily JMA. The Wayfinding Questionnaire: A clinically useful self-report instrument to identify navigation complaints in stroke patients. Neuropsychol Rehabil. 2019 Aug;29(7):1042-1061. doi: 10.1080/09602011.2017.1347098. Epub 2017 Jul 18.

  PMID: 28720024 BACKGROUND

• van der Ham IJ, Kant N, Postma A, Visser-Meily JM. Is navigation ability a problem in mild stroke patients? Insights from self-reported navigation measures. J Rehabil Med. 2013 May;45(5):429-33. doi: 10.2340/16501977-1139.

  PMID: 23615778 BACKGROUND

• Claessen MHG, Visser-Meily JMA, de Rooij NK, Postma A, van der Ham IJM. The Wayfinding Questionnaire as a Self-report Screening Instrument for Navigation-related Complaints After Stroke: Internal Validity in Healthy Respondents and Chronic Mild Stroke Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):839-854. doi: 10.1093/arclin/acw044.

  PMID: 27506237 BACKGROUND

• Hegarty, M., Montello, D. R., Richardson, A. E., Ishikawa, T., & Lovelace, K. (2006). Spatial abilities at different scales : Individual differences in aptitude-test performance and spatial-layout learning. Intelligence, 34(2), 151-176. https://doi.org/10.1016/j.intell.2005.09.005

  BACKGROUND

MeSH Terms

Conditions

Orientation, Spatial

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Central Study Contacts

EL AKHDAR Hajar, Master Science

CONTACT

0383153596; h.elakhdar@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

FR (1)