NCT06441552招募中不适用
Learning the Natural History of Recovery After Stroke - Cognitive, Motor and Sensory Function
Adi Negev-Nahalat Eran3 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
The goal of this longitudinal observational study is to learn the course of recovery after stroke. Specifically, in this study we will learn and describe the changes in cognitive, motor and sensory function over time in stroke patients.
详细描述
This study constitutes the first step in the RESTRO project: Evaluation of an accessible and affordable neurorehabilitation program to promote recovery and to enhance the quality of life after stroke. In this study, we will monitor sensorimotor and cognitive functions of Stroke patients along the first 6 to 12 month following their stroke. Data from three primary sites will be collected and compared in several time points, and its relation to the type and intensity of the rehabilitation program, usually provided in each site, will be tested.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years of age
- •Independent in all activities of daily living before the stroke.
- •In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center, with first ever stroke, or with a recurrent stroke that did not lead to disability (were independent in ADL before the second stroke).
- •Medically stable
- •Able to provide informed consent.
排除标准
- •The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes.
- •Traumatic brain injury and/or extra-cerebral hemorrhage.
- •Significant psychiatric condition, including alcoholism and drug abuse.
- •Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.
- •Participation in another interventional study.
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Fugl-Meyer Assessment: Motor score is on a 0-100 scale. High score is better.
Action Research Arm Test (ARAT)
时间窗: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Action Research Arm Test Score is on a 0-57 scale. High score is better.
10-meter walk test (10MWT)
时间窗: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Outcome is the average walking velocity over 10 meters. Measured in m/sec.
次要结局
- The Stroke Self-Efficacy Questionnaire (SSEQ)(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- The Ashworth scale(Baseline (<3weeks))
- Supporting data-age(Baseline)
- Supporting data-time2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- supporting data-medical history(Baseline)
- Cognition-inhibition2(one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- National Institutes of Health Stroke Scale (NIHSS)(Baseline (<3weeks))
- The Nine Hole Peg Test (NHPT)(Baseline (<3weeks), 1-year)
- The Functional Dexterity Test (FDT)(Baseline (<3weeks), 1-year)
- The Behavioral Inattention Test (BIT)(Baseline (<3weeks))
- Kinetics-fingers1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Kinematics-Inter-joint coordination(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Rehabilitation-intensity(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Rehabilitation-time(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Supporting data-sex(Baseline)
- anthropometric data-height(Baseline)
- supporting data-directional(Baseline)
- Cognition-impairment(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gaze-downward(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Kinetics-fingers2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Kinetics-grip(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Kinematics-reaching(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Kinematics-duration(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Kinematics-smoothness(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Rehabilitation-period(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Supporting data-time1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- anthropometric data-weight(Baseline)
- Cognition-inhibition1(one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gait Specific attentional profile (G-SAP)(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gait analysis-spatial(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gait analysis-steadiness(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gaze-angle2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gaze-look-ahead distance(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Muscle controllability1(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Muscle controllability3(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Timed up and Go test (TUG)(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gait analysis-temporal(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Gaze-angle1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Balance-Berg(baseline)
- Balance-postural steadiness1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Balance-postural steadiness3(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Habitual activity1(one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Balance-postural steadiness2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Balance-postural steadiness4(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Habitual activity2(one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Sensory-tactile(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Coordination-LE1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Coordination-LE2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Reticulospinal excitability(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Muscle controllability2(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
- Neuroimaging(one or more of :1-month, 3-month, 6-month, 1-year)
研究者
研究点 (3)
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