Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Balance score
研究概览
简要总结
The main objective of this monocentric, non-randomized, prospective study was to evaluate the predictive capacity of a balance score based on spatio-temporal parameters of postural balance.
详细描述
Patient recruitment will take place at one center. The inclusion period is 6 months and the participation period for each subject will be 12 months with 3 visits: initial visit, telephone visit at 6 months, M12 consultation visit, and the end-of-study visit.
Consent will be obtained prior to participation, and the following data will be collected during the visits: Demographic data (age, gender), weight, height, geriatric assessment. Current treatment (molecules, date of introduction, dosage). Biological data: Albumin, Pre-Albumin, Creatinine, Hemoglobin, Vitamin D.
Static balance parameters via AbilyCare (static balance test, inspired by the Romberg test, on a balance platform, 30 seconds eyes open then 30 seconds eyes closed).
The total duration of the research is 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with a "Autonomie, Gérontologie, Groupes IsoRessources" (GIR) score ≥ 4 at the time of consultation
- •Subject presenting an The mini mental status exam (MMSE) score ≥ 18 at the time of consultation
- •Subject agreeing in writing (consent), after having been informed and given a reasonable period of reflection, to participate in the study
- •Subject affiliated to a social security scheme.
排除标准
- •Subjects with a major or systemic pathology likely to significantly impair motor skills (inability to perform a 10m walking test without assistance, inability to perform a balance test on a scale without assistance (30 seconds eyes open / 30 seconds eyes closed),
- •Subject with an advanced neurodegenerative pathology (Alzheimer, Parkinson, etc.) deemed incompatible with the objectives of the study by the investigator,
- •Subjects with a history of disabling cerebrovascular accident,
- •Subject with an active disabling cancer,
- •Subjects with severe psychiatric disorders affecting their ability to perform walking and balance tests and/or answer study questionnaires,
- •Subjects benefiting from a technical aid for walking and balance such as a cane, walker, etc. (only orthopedic insoles and shoes are accepted); subjects with a total hip or knee prosthesis are included,
- •Subject having been hospitalized for a fall in the last 3 months prior to inclusion,
- •Subject unable to understand the purpose of the research, answer questions and give his/her decision to participate in the study,
- •Subject already included in another research study involving the human body,
- •Subject not affiliated to a social security scheme or not benefiting from such a scheme.
- •Person deprived of liberty by judicial or administrative decision
- •Person of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) or unable to express consent.
结局指标
主要结局
Balance score
时间窗: 12 months
The balance score, based on a learning model incorporating spatio-temporal parameters of pressure center displacement. These parameters include amplitude along the anterior-posterior and medio-lateral axes, surface area covered, and displacement speed. The overall score is calculated on the basis of model-building data from profiles of people with and without previous falls. This score, evaluated from 0 to 100, indicates the level of balance, with a score of 99 representing optimal balance. The lower the score, the more precarious the balance, thus approximating a potential faller profile.
次要结局
- Evaluation of the association between each static balance indicator and fall occurrence(12 months)