Structural Validity and Inter-rater Reliabitiliy of the Ataxia Trunk, Lower And Upper Extremity Scale (ATLAS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Ataxia Trunk, Lower And upper extremity Scale scores (ATLAS)
研究概览
简要总结
Ataxia is a neurological disorder affecting coordination, caused by damage to the cerebellum, brainstem, or related pathways. It can be hereditary (e.g., Friedreich's ataxia) or acquired (e.g., multiple sclerosis, stroke). Though rare, ataxia significantly impacts quality of life and independence. Treatments are limited and mainly focus on multidisciplinary rehabilitation. Accurate assessment is essential, yet current tools like Scale for the Assessment and Rating of Ataxia (SARA) have limitations. This study aims to validate a new scale, named the Ataxia Trunk, Lower And upper extremity Scale (ATLAS), through Rasch analysis, to develop a shorter, reliable version. It will assess internal consistency, construct validity, and inter-rater reliability.
For the valitdity part, statistics will be used (1) to see if the different items of the scale are indeed different and complementary to each other, and (2) to compare the results of this scale with other scales already known and valid (SARA, Trunk Impairment Scale (TIS) and Functional Impairment Measurement(FIM)). Secondly, the investigators would like to know whether ATLAS is reliable. In this particular case, the reliability being assessed is inter-rater reliability, i.e. whether all raters give the same score on the items performed by the patient. To carry out such a study, 64 people will be needed to achieve these goals. Each person will complete the 20 items of the ATLAS scale, those of a trunk motor capacity assessment (TIS), and will evaluate his or her functional independence (FIM).
详细描述
Ataxia, derived from the Greek word ataxia meaning "disorder," is a neurological condition characterized by impaired coordination of oculomotor movements, upper limbs (UL), lower limbs (LL), and trunk, as well as dysarthria. Most of these symptoms lead to disturbances in postural control and gait. Ataxia may result from damage to the cerebellum, brainstem, and/or ascending pathways.
In addition to these motor impairments, vestibulocerebellar syndrome and cerebellar cognitive affective syndrome (also known as Schmahmann's syndrome) contribute to difficulties in regulating cognitive, motivational, and emotional states in affected individuals.
Ataxias are broadly classified into two main categories:
I) Hereditary or genetic ataxias, with an overall prevalence of approximately 2.7-38.35 per 100,000, include Friedreich's ataxia (autosomal recessive), other autosomal recessive ataxias (average prevalence of 3.3 per 100,000), and spinocerebellar ataxias (mostly autosomal dominant, average prevalence of 2.7 per 100,000).
II) Acquired ataxias, which may result from multiple sclerosis (MS; 100 per 100,000, with 10-50% showing signs of ataxia), stroke, traumatic brain injury (TBI), tumors, infections, vitamin deficiencies, or exposure to toxic substances such as alcohol, heavy metals, or medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be adults
- •Be able to provide written informed consent
- •Be able to understand and follow simple physical instructions
- •Have a diagnosis of genetic or hereditary ataxia, or a cerebellar or pontine stroke (either hemorrhagic or ischemic), confirmed by a neurologist
排除标准
- •Muscle group strength < 3 on the Medical Research Council (MRC) scale
- •Spasticity > 2 in any muscle on the Modified Ashworth Scale
- •Pain > 5 on the Visual Analogue Scale (VAS) in any part of the body
结局指标
主要结局
Ataxia Trunk, Lower And upper extremity Scale scores (ATLAS)
时间窗: Once, at day 1
The Ataxia Trunk, Lower And upper extremity Scale (ATLAS) includes 20 items: 14 related to the trunk, 3 to the lower limbs (LL), and 3 to the upper limbs (UL). Each item is rated using an ordinal scale ranging from 2 to 4. A maximum total score of 64 indicates severe ataxia, while a score of 0 reflects the absence of ataxia. The maximum subscore for the trunk is 28, for the lower limbs 18, and for the upper limbs 18, with each side assessed separately.
次要结局
- Functional Independence Measure (FIM)(Once, at day 1)
- Trunk Impairment Scale 2.0 (TIS 2.0)(Once, at day 1)
- Scale for the Assessment and Rating of Ataxia (SARA)(Once, at day 1)
研究者
HESAV Health Research Unit
Lecturer
Haute Ecole de Santé Vaud