Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease

Official title

Evaluation Subjective Des CApacités d'Orientation sPatialE Dans la mAladie D'Alzheimer

Overview

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.

Interventions

• Diagnostic test Questionnaire d'Orientation Spatiale (QOS)
  French version of the wayfinding questionnaire

Primary outcome measures

• French version of the QOS Score [Time frame: Baseline and between 30 and 90 days after baseline for groups A1, A2, A3, B1 and B2]

Eligibility criteria

Inclusion criteria

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):

• Caregivers of a person with dementia included in group A, with regular contact (at least 10 hours per week, spread over a minimum of 3 times per week)
• Healthy control subjects (group C):
• Aged 55 to 85
• Able to walk independently, i.e., without assistance, whether human or technical, except for a single cane
• Normal performance on the Folstein Mini-Mental State Examination (MMSE), according to GRECO (Cognitive Assessment Task Force) standards

Exclusion criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

France · 1 center

• CHRU (Centre Hospitalier Régionale Universitaire) Nancy — Nancy

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07616063 · 2019PI271 · N°ID-RCB : 2025-A00441-48

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗