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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：EL AKHDAR Hajar, Master Science
- 電話番号：0383153596
- メール：h.elakhdar@chru-nancy.fr
研究場所
-
-
-
Nancy、フランス、54500
- CHRU (Centre Hospitalier Régionale Universitaire) Nancy
-
コンタクト：
- Hajar EL AKHDAR
- 電話番号：+33 3 83 15 35 96
- メール：h.elakhdar@chru-nancy.fr
-
主任研究者：
- Thérèse JONVEAUX, Dr
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
French version of the QOS Score
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
空間方向性の臨床試験
-
Assistance Publique - Hôpitaux de Paris完了脳血管障害 | 脳卒中 | VISIO-空間無視 | VISUO-spatial Extinctionフランス