The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Movement performance assessment
研究概览
简要总结
In literature review, thermal stimulation (TS) intervention is effective in facilitating upper extremity functional recovery in stroke patients. In addition, several functional MRI studies have indicated that thermal stimuli promoted activation in the premotor and motor cortices of healthy participants. These imply the possibility of TS in cortical reorganization. However, there were no studies exploring the relationship of the TS intervention and cortical reorganization. By the functional recovery of stroke patients, findings of brain image and brain mapping, it could enhance the understanding the TS influences on brain reorganization. Regarding with clinical application of the TS intervention for improving functional performance of upper extremity in participants with stroke, the best parameters of TS intervention in clinical practice have not been decided. Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute, chronic) undergoing TS intervention with different parameters. Functional scales, kinematic data, brain image were taken in several timelines as outcome measures.
详细描述
The thermal stimulation (TS) intervention uses the heat and cold apply alternately (~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.
There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •first-ever ischemic stroke;
- •no severe cognitive impairments and able to follow instructions;
- •sit on a chair for more than 30 minutes independently.
排除标准
- •musculoskeletal or cardiac disorders that potentially interferes with experimental tests;
- •diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;
- •speech disorder or global aphasia;
- •skin problems at the sites of stimulation;
- •6.contraindications of heat or ice application.
结局指标
主要结局
Movement performance assessment
时间窗: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
* Movement performance assessment by clinical motor assessment scales in upper extremity * executed by qualified physiotherapy * in study A, B, C
Kinematics measure of upper extremity movement
时间窗: four timeline
* 1st day and 24th of intervention, one-month follow-up, six-month follow-up (This examination is optional) * signal emission marks are sticked on surface skin during motion tests * this examination is optional --in study A. * executed by trained qualified physiotherapy
Mapping of brain cortex
时间窗: immediate effect in four timeline
* "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day * immediate effects of intervention in the 1st day and 24th of intervention, one-month follow-up, six-month follow-up * in study A. * this examination is optional * use equipment of brain mapping and operated under trained staff, the attending is consulted This examination can be stopped at any time if participants do not want to perform or feeling unwell
Brain images
时间窗: immediate effects in 3 timeline
* "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day * immediate effects of intervention in the 1st day and 24th of intervention, six-month follow-up * this examination is optional * in study A. * use regular scan examination of hospital and operated by trained qualified professionals, the attending is consulted * This examination can be stopped at any time if participants do not want to perform or feeling unwell
次要结局
- Quality of life(baseline, post-intervention, 6 month follow-up)
研究者
Jau-Hong Lin, Professor
Professor in Department of Physical Therapy, Kaohsiung Medical University, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital