Study of the Metrological Properties of Two Assessment Grids of the Driving Capacity After a Cerebrovascular Accident :Recommendations of the HAS (Hight Autority of Health in France) and Test Ride for Investigation Practical Fitness to Drive
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
研究概览
简要总结
Precise recommendations concerning the methods of evaluation for the resumption of the driving after a not evolutionary stroke were recommended recently by the High Authority of Health. These describe among others elements to be estimated during the test on the road, in the presence of the driving instructor who remains Gold standard.
However, no standardized assessment grid serving as decision-making tool is at present validated.
Actually the test made by the unit of evaluation of the automobile resumption of the university hospital on the road, in a car of apprenticeship with double pedals and in the presence of a professional binomial (driving instructor and occupational therapist) then validated by the opinion of the doctor of the service. The current standard is thus very subjective and lack of sensibility.
It is necessary to study the metrological properties of both available assessment grids (that established from the recommendations of the HAS and TRIP), none of them reached a level of validation enough in this population.
The TRIP is this day validated only at the elderly people. The hypothesis of the search is an insufficiency of TRIP to estimate the patients presenting aftereffects of cerebrovascular accident.
The main objective of this work is to validate the new assessment grid after a study of its metrological properties in the situation of the driving on the road.
详细描述
The patients will benefit a medical consultation to estimate the possibility of inclusion in the study. During this consultation, the results of the neuropsychological and ophthalmological examinations will be explored and a specificity of the sensitive-driving deficits presented by the patient will be estimated to recommend the arrangements of necessary vehicle if necessary.
All the inclusive patients will benefit then the first test of driving in "ecological" situation accompanied by a lasting driving instructor during 45minutes. The evaluation will be realized by a present occupational therapist and a neuropsychologist in the vehicle, on two different assessment grids.
The second test on road will be for the part of included patients and will be made with the driving instructor and the therapist.
Then, the third test on road will be realized after sessions on driving simulator for the part of the patients requiring a re-entrainment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 Years to 80 Years
- •Cognitive and/or sensitive-motor disorders after a cerebrovascular accident
- •Candidate for resumption of driving on the road and having to pass an aptitude test
- •French legal protection
排除标准
- •Contraindications for resumption of driving on the road (visual field amputation, binocular visual acuity less than 5/10; cognitive impairment not compatible with driving; other medical contraindication).
- •Protected populations not concerned by the study (guardianship, curatorship, deprived of the freedoms, safeguarding of justice).
结局指标
主要结局
The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
时间窗: at 3 months
Acceptability will be based on the calculation of missing data at the level of each item and for the overall score of the study grids. Internal Consistency will be determined through Cronbach's alpha coefficient. Internal validity will be determined by study of correlation between the domains composing of the HAS and TRIP grids. Reproducibility .the Kappa concordance correlation coefficient will be used to determine the test-retest reliability. Internal validity will be determined by study of the correlation between of HAS and TRIP grids. External validity will be based on the study of correlations of scores from HAS and TRIP grids (Pearson or Spearman according to statistical distribution).
次要结局
- The sensitivity to change(at 1 month)