Effect of Eccentric Contraction-based Resistance Exercise on Functional Recovery in Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Isokinetic knee extensor strength
研究概览
简要总结
The purpose of this study is to develop an evidence-based rehabilitation treatment method suitable for recovery and improvement of physical function in chronic stroke patients using an eccentric overload flywheel device. Participants are disabled with chronic stroke (ischemic and hemorrhagic cerebral hemorrhage) over 50 years of age, who can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher, and whose functional gait score is 3-5 points. The investigators will enroll 40 participants and randomly assign them to either the control (Con, n=20) or the exercise (Ex, n=20) group. The investigators will verify the effectiveness of the exercise program through the evaluation of changes in muscle and physical function before and after intervention in both groups.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with disabilities 50 years of age or older who have been diagnosed with a stroke (ischemic and hemorrhagic cerebral hemorrhage) for at least one year
- •Patients can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher
- •Patients have a functional ambulation category (FAC) score of 3 to 5
排除标准
- •Patients with brain lesions and quadriplegia excluding stroke
- •Patients with uncontrolled hypertension with limited exercise intervention
- •Patients diagnosed with angina
- •Patients with congestive heart failure (CHF)
- •Patients with upper/lower extremity fracture within 6 months
结局指标
主要结局
Isokinetic knee extensor strength
时间窗: Change from Baseline muscle function at 8 weeks of intervention.
Evaluation of change from baseline isokinetic knee extensor strength to 8 weeks after the initial assessment. Isokinetic knee extensor strength is measured in peak torque (Nm) achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 60° per second.
Short physical performance battery (SPPB) scores
时间窗: Change from Baseline physical function at 8 weeks of intervention.
Evaluation of change from baseline SPPB score to 8 weeks after the initial assessment. The SPPB is a group of measures that combine the results of the gait speed, timed chair stand and balance tests. For the static standing balance test, participants were asked to stand in side-by-side, semi-tandem and tandem positions, and maintain each position for 10 s. For the gait speed test, participants were asked to walk along a 4-m distance at their normal walking speed. For the repeated chair rise test, participants were asked to fold their arms across their chest and stand up from a sitting position five times consecutively as quickly as possible. Performance scores for each SPPB individual test and a summary score aggregating the individual tests were calculated as per standard SPPB protocol (range 0-12). The scores range from 0 (worst performance) to 12 (best performance).
次要结局
- Hand grip strength(Change from Baseline physical function at 8 weeks of intervention)
- Isotonic knee power(Change from Baseline physical function at 8 weeks of intervention)
- Isometric knee strength(Change from Baseline physical function at 8 weeks of intervention)
- Timed up and go(Change from Baseline physical function at 8 weeks of intervention.)
- Isokinetic knee extensor eccentric strength(Change from Baseline muscle function at 8 weeks of intervention.)
研究者
Jae-Young Lim
Professor, Department of Rehabilitation Medicine
Seoul National University Bundang Hospital