Associations Between Contextual Interference, Engagement During Treatment, and Change in Motor Performance Among Patients Posts-stroke
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Brain Engagement Index
研究概览
简要总结
The aim of the study is to examine associations between contextual interference (CI), engagement during practice and changes in upper limb motor performance among patients post-stroke.
Fifty patients over the age of 18, after a stroke, in the sub-acute and early chronic stages who have weakness of the upper extremity and are treated in a rehabilitation center will be recruited.
The study will include participation in five sessions: session 1 for baseline assessment, session 2-4 for practice of upper extremity functions, and session 5 for post intervention assessment. The intervention will include training of three items from the Wolf motor function test in random order (high CI group) or block order (low CI group). Outcomes of engagement will include the brain engagement index, heart rate variability and galvanic skin response. Outcomes of learning will include the pre-post change in performance of the wolf motor function selected items.
详细描述
The aim of the study is to examine associations between contextual interference (CI), engagement during practice, and changes in upper limb motor performance among patients post-stroke.
Fifty patients over the age of 18, after a stroke, in the sub-acute and early chronic stages who are treated in a rehabilitation center inpatient or outpatient clinics, who have hemiparesis (Fugl-Meyer score = 11-60) will be recruited.
Patients with a history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function, pain that prevents active movement, hemodynamic instability, cognitive decline and language difficulties that do not allow understanding of instructions and cooperation will be excluded.
The study will include participation in five sessions. In the first session, participants will answer a demographic questionnaire and a set of motor (including the Wolf motor function test), perception and cognitive tests will be delivered. Then participants will be assigned to either high or low CI groups. In the next three sessions, participants will practice three items from the Wolf motor functions test. Participants in the high CI group will practice the items in random order and those in the low CI group will practice the selected items in blocked order. Assessment of outcomes during practice will include assessment of brain engagement index by recording EEG (one electrode) and heart rate variability and galvanic skin response. In the fifth session, at the end of the intervention, a reassessment of the wolf motor function performance will be performed.
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
- Single (Outcomes Assessor)
盲法说明
Masking description: The outcome assessor will be blind to the group assignment of the participants. Participants and the investigator who deliver the intervention will be aware of group assignment because it is inherent to the type of practice they receive and deliver respectively.
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
- •Five days to 1-year post-stroke
- •Score of 11-60 on the Fugl-Meyer Assessment for upper extremity
- •The patient receives physical therapy and/or occupational therapy rehabilitation treatment
排除标准
- •A history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function
- •Pain that prevents active movement of the upper extremity
- •Hemodynamic instability
- •Cognitive decline and language difficulties that do not allow understanding of instructions and cooperation.
结局指标
主要结局
Change in Brain Engagement Index
时间窗: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
EEG activity in the prefrontal cortex will be measured by MindWave mobile EEG headset.
Change in time to complete each of three items of the Wolf Motor Function Test (WMFT)
时间窗: Pre-intervention session (first session), post-intervention session (session 5, 5-7 days following the pre-intervention session))
A maximum of 120 seconds is allowed. Any performance that exceeds 120 seconds is assigned 120 seconds.
次要结局
- Changes in Galvanic Skin Response (GSR)(Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1))
- Changes in Heart rate variability(Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1))
研究者
Michal Kafri, PhD
Principal Investigator
University of Haifa