Characterization of the Neuromuscular and Biomechanical Properties of Spastic Myopathy-affected Muscles During the Generation of Passive and Active Force: the Effect of a Management Program Based on Eccentric Exercises.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- gait speed (m/s) through the 10-meter walking test.
研究概览
简要总结
The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Secondary objectives involve assessing: i) modifications in neuromuscular parameters of PF, ii) changes in muscle stiffness within PF during passive mobilization and active force generation, and iii) modifications in architectural parameters of PF.
详细描述
This study will be a single-blinded, controlled, randomized design, wherein participants will be randomly assigned to one of two groups: the Conventional Therapy Group (CTG) or the Eccentric Training Group (ETG). Both groups will undergo a comprehensive series of assessments at three key time points: Ji (initial assessment), Jint (intermediate assessment), and Jf (final assessment). The study will commence with a recruitment phase, followed by a screening phase. Subsequently, there will be a 4-week period allocated for experimental testing before the intervention, and an additional 4 weeks for experimental testing after the intervention. These assessments will encompass a wide range of evaluations, including clinical health assessments, biomechanical assessments, neuromuscular evaluations, and functional assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subacute hemiparesis (> 3 months)
- •BMI between 18.5 and 25
- •Written consent to participate in the study.
排除标准
- •Ankle impairment
- •Botulinum toxin injections in PF within the last 4 months before study inclusion
- •Medical contraindication for maximal effort
- •Neurodegenerative disorders
- •Cardiovascular disorders
- •History of epilepsy.
结局指标
主要结局
gait speed (m/s) through the 10-meter walking test.
时间窗: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
An analysis of the walking pattern will be conducted to quantify the evolution of spatio-temporal and barometric parameters of walking and their asymmetry.
次要结局
- Neuromuscular parameters(initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion)
- Structural parameters(initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion)
- Functional parameters(initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion)
- Biomechanical proprieties(initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion)
研究者
Belghith Kalthoum
Principal investigator
Clinique Du Parc de Belleville