Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline in Barthel index at 8 weeks
研究概览
简要总结
The purpose of this study is to analyze the effects of a mixed intervention of occupational therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and moderate patients post stroke in comparison to a control group with a traditional health educative protocol.
详细描述
Apraxia is a neurological disorder characterized by a loss of ability to execute and carry out skilled movements and gestures despite intact motor and sensory systems, coordination and comprehension.
Upper limb apraxia comprises a wide spectrum of higher motor disorders caused by acquired brain disease, affecting the performance of skilled movements carried out by the upper limbs.
Few data are available on the effectiveness of interventions in this disorder and no exists studies that implement a mixed intervention (rehabilitative and compensatory ) of Occupational Therapy in these patients at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild-moderate stroke after two month of the cerebrovascular attack.
- •Upper limb apraxia lasting at least 2 months.
- •Less than 9 points in validated Apraxia Screen of TULIA (AST) following Vanbellingen et al.,
- •Voluntary participation.
- •The neurologist, the occupational therapist and the patient judge the intervention to be necessary.
排除标准
- •History of apraxia before current stroke.
- •Stroke had occurred less than two months or more than twenty four month ago.
- •Cognitive impairment (< 23 in normal school population and < 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).
- •Severe aphasia.
- •Previous brain tumour.
- •History of other previous neurologic disorders.
- •Mother tongue different to Spanish.
- •Drugs addiction.
- •Intellectual or learning disorders.
- •Brain damage for traumatism or neurodegenerative process.
- •A history of serious consciousness impairments
- •Uncooperativeness, presence of orthopedic or other disabling disorders.
研究组 & 干预措施
Functional Rehabilitation of apraxia
The participants will be randomly assigned to an experimental group, to receive intervention in upper limb apraxia at home since two approaches, a rehabilitative and another compensatory (providing adaptive strategies at home). The treatment will be performed three times a week, 30 minutes a day, during a 4-week period.
干预措施: Functional Rehabilitation of apraxia (Other)
Traditional health educative protocol
Control group will receive treatment with a traditional health educative protocol to improve his functionality in activities of daily living. The treatment will be performed twice in two month.
干预措施: Traditional health educative protocol (Other)
结局指标
主要结局
Change from Baseline in Barthel index at 8 weeks
时间窗: Eight weeks
This test can be recommended as an instrument of choice for measuring physical disability and is useful in assessing functional disability in basic activities of daily living, obtaining a quantitative estimate of the degree of dependence of the subject. It has good interobserver reliability with Kappa index between 0.47 and 1.00. According to intraobserver reliability, Kappa index between 0.84 and 0.97 was obtained.
Change from Baseline in Barthel index at 16 weeks
时间窗: Sixteen weeks
次要结局
- Change from baseline in Quality of life scale for stroke (ECVI-38) at 16 weeks(Sixteen weeks)
- Change from baseline in observation and scoring of ADL-Activities at 8 weeks(Eight weeks)
- Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 8 weeks(Eight weeks)
- Change from baseline in De Renzi Test (ideational apraxia) at 8 weeks(Eight weeks)
- Change from baseline in De Renzi Test (ideomotor apraxia) at 8 weeks(Eight weeks)
- Change from baseline in recognition of gestures (Smania, 2000) at 8 weeks(Eight weeks)
- Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 16 weeks(Sixteen weeks)
- Change from baseline in recognition of gestures (Smania, 2000) at 16 weeks(Sixteen weeks)
- Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 8 weeks.(Eight weeks)
- Change from baseline in De Renzi Test (ideomotor apraxia) at 16 weeks(Sixteen weeks)
- Change from baseline in Quality of life scale for stroke (ECVI-38) at 8 weeks(Eight weeks)
- Change from baseline in observation and scoring of ADL-Activities at 16 weeks(Sixteen weeks)
- Change from baseline in De Renzi Test (ideational apraxia) at 16 weeks(Sixteen weeks)
- Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 16 weeks.(Sixteen weeks)
研究者
Encarnación Aguilar Ferrandiz
Functional Rehabilitation of upper limb apraxia in patients Poststroke: Randomized Clinical Trial
Universidad de Granada