Triceps Surae Muscle Characteristics in Hemiparetic Stroke Survivors: Clinical Implications From Ultrasonographic Evaluation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- muscle structure variations
研究概览
简要总结
This study aims to evaluate, in hemiparetic patients, changes in muscle ultrasound structure about the focal treatment of spasticity with botulinum toxin type A. For this purpose, the analysis of the mean echo intensity will be carried out on ultrasound acquisitions, identifying the possible correlations between the muscle echogenicity, the variations in the pennation angle, and the length of the fascicles.
For image processing operations, ImageJ software was applied.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •unilateral ischaemic or haemorrhagic stroke (documented with clinical examination and neuroradiological findings)
- •presence of spasticity at lower limb muscles, at least grade 1+ in the modified Ashworth Scale
- •age ≥ 18 years
排除标准
- •inability to walk before stroke
- •presence of severe cognitive impairment
- •presence of other musculoskeletal, neurological or cardiopulmonary impairment which can interfere with clinical findings
- •presence of skin lesions that can contraindicate BoNT-A treatment
- •previous surgical myotendinous elongation
结局指标
主要结局
muscle structure variations
时间窗: single measure through study completion (1 year)
The primary outcome consists in detecting muscle structure variations during the procedure. This measure will be related to the time frame between the first inoculation and the moment of image acquisition, and to the number of therapeutic cycles performed. The aim is to determine the potential correlation between BoNT-A injection and muscle structure evolution. The time point of assessment is not pre-defined but the time since stroke onset and, if applicable, from the first BoNT-A injection will be recorded. Each participant will be assessed once during the overall duration of the study.
次要结局
未报告次要终点
研究者
Alessio Baricich
Professor in Physical and Rehabilitation Medicine
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"