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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: EL AKHDAR Hajar, Master Science
- 전화번호: 0383153596
- 이메일: h.elakhdar@chru-nancy.fr
연구 장소
-
-
-
Nancy, 프랑스, 54500
- CHRU (Centre Hospitalier Régionale Universitaire) Nancy
-
연락하다:
- Hajar EL AKHDAR
- 전화번호: +33 3 83 15 35 96
- 이메일: h.elakhdar@chru-nancy.fr
-
수석 연구원:
- Thérèse JONVEAUX, Dr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Patients Group
Patients with Alzheimer disease
|
French version of the wayfinding questionnaire
|
|
Accompanying persons
Relatives (friends or family) of patients with alzheimer disease
|
French version of the wayfinding questionnaire
|
|
Control arm
Healthy participants
|
French version of the wayfinding questionnaire
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
French version of the QOS Score
기간: Baseline and between 30 and 90 days after baseline for groups A1, A2, A3, B1 and B2
|
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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2019PI271
- N°ID-RCB : 2025-A00441-48 (기타 식별자: ANSM (The National Agency for Drug and Health Product Safety))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .