- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07616063
Subjective Assessment of Spatial Orientation Abilities in Alzheimer's Disease (ESCAPE-AD)
Evaluation Subjective Des CApacités d'Orientation sPatialE Dans la mAladie D'Alzheimer
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: EL AKHDAR Hajar, Master Science
- Telefonní číslo: 0383153596
- E-mail: h.elakhdar@chru-nancy.fr
Studijní místa
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Nancy, Francie, 54500
- CHRU (Centre Hospitalier Régionale Universitaire) Nancy
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Kontakt:
- Hajar EL AKHDAR
- Telefonní číslo: +33 3 83 15 35 96
- E-mail: h.elakhdar@chru-nancy.fr
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Vrchní vyšetřovatel:
- Thérèse JONVEAUX, Dr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Patients Group
Patients with Alzheimer disease
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French version of the wayfinding questionnaire
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Accompanying persons
Relatives (friends or family) of patients with alzheimer disease
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French version of the wayfinding questionnaire
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Control arm
Healthy participants
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French version of the wayfinding questionnaire
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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French version of the QOS Score
Časové okno: Baseline and between 30 and 90 days after baseline for groups A1, A2, A3, B1 and B2
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There are three sub-scores in total :
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
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2019PI271
- N°ID-RCB : 2025-A00441-48 (Jiný identifikátor: ANSM (The National Agency for Drug and Health Product Safety))
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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