Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- SOT equilibrium scores on conditions 1-6.
研究概览
简要总结
The purpose of this pilot study is to characterize changes in postural orientation and equilibrium in early diagnosed ALS patient. The investigators plan to cross validate the use of a standardized test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in early diagnosed ALS patients.
详细描述
ALS is a progressive neurodegenerative disorder involving primarily upper and lower motor neurons. The progressive loss in motor neurons leads to weakness, fatigue, spasticity, and loss of balance. Falls are reported in 30-35% of ALS patients prior to enrolment to ALS clinic. This early loss of balance may not be detected by the classical neurological exam, or the standard clinical balance scales. Understanding the impairments in the balance control system which leads to fall during the course of ALS is a prerequisite for the clinical decision-making process in order to develop a proper balance rehabilitation program and fall prevention strategies for these patients.
Patients and control subjects will undergo balance system evaluation consisting of the following testing:
- Sensory Organization Test Protocol
Standardized EquiTest assessment protocol:
Sensory Organization Test (SOT) - will be used to measure change how well participants maintain balance under progressively more difficult test conditions, which either disrupt or remove visual and proprioceptive feedback. Visual and proprioceptive environments will be altered systematically for fixed support and sway-referenced support and surround conditions, and under normal (eyes open), absent (eyes closed), and sway-referenced vision (eyes sway-referenced). Under sway-referenced conditions, the platform on which the subject stands and/or the visual surround also move proportionally to their AP sway. During SRC the floor and visual surround are controlled by a servomechanism (Gain=1.0) to follow movements of the subjects' center of gravity. Sway-referencing eliminates accurate somatosensory and/or visual information used to orient the body. Performance under sway-referenced visual conditions shows the participant's ability to suppress conflicting visual inputs and to rely on alternative systems for maintaining equilibrium (table 1).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for subjects with early ALS:
- •Probable or definite ALS according to World Federation of Neurology diagnostic criteria
- •Early stage ALS defined as presence of:
- •Normal lower extremities muscle strength (≥ 4/5 in manual muscle strength or ≥ 80% in the computerized dynamometer quantitative muscle strength);
- •ALSFRS score of ≥ than 30;
- •FVC of ≥75% predicted;
- •Ambulatory without the use of any assistive device.
- •18 - 75 years of age.
- •Able to provide informed consent.
- •Inclusion Criteria for control subjects:
- •Healthy 18 - 75 years of age without significant medical condition as defined by the investigator.
- •Able to provide informed consent.
- •Not having any of the exclusion criteria listed below.
排除标准
- •Age < 18 or > 75 years.
- •History of falls (2 or more in the last year), history of fainting, history of cerebrovascular accident (CVA) or myocardial infarction (MI), history of lower limb joint replacement.
- •History of neuromuscular dysfunction "except diagnosis of ALS for individuals with ALS".
- •Post-traumatic, septic, inflammatory, or neuropathic arthritis.
- •Lower extremity injury/surgery that may effect balance.
- •Vestibular pathology (i.e., inner ear problems, vertigo, meniere's).
- •Peripheral neuropathy.
- •Parkinson's Disease.
- •Currently taking anti-convulsive medications (e.g., clonazepam, diazepam, lorazepam,phenytoin, zonegran, carbamazepine, depakote, gabapentin, lamotrigine, lamotrigine, oxcarbazepine, tiagabine, topiramate)
- •Diabetes Mellitus.
- •No history of neurological or medical condition that may interfere with balance as defined by investigators.
结局指标
主要结局
SOT equilibrium scores on conditions 1-6.
时间窗: 9 monthes
次要结局
- MSS on conditions 1-6 Weight Symmetry Score on conditions 1-6 DGI score TUG score POMA-B score(9 months)
