Morphological Characteristics of Spastic Musculature in the Upper and Lower Extremities Using Ultrasound Examination in Subjects After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Spasticity
研究概览
简要总结
Introduction A large number of stroke patients develop spasticity in the upper and lower extremities, which is one of the clinical signs of damage to motor neuron 1, causing abnormal postures and movement patterns due to motor neuron hyperexcitability and rheological alterations in the affected muscles. These alterations limit the use of the arm and leg, restricting their use in functional activities and affecting the quality of life and social participation of users. In recent years, the Heckmann scale has been used to evaluate spastic muscle alterations by ultrasound; however, evidence is limited regarding its benefits as an assessment tool for spastic hypertonia.
Objective To describe the morphological characteristics of spastic muscles in the lower extremities using ultrasound examination in subjects after stroke.
Method A prospective, multicenter descriptive study will be conducted. The sample will be non-probabilistic, consisting of 80 subjects who meet the eligibility criteria and provide informed consent.
Analysis of results Using the SPSS 27 program, a descriptive analysis will be performed using statistical indices of central tendency, dispersion, and distribution according to the measurement scale of each variable. The normality of the distribution of continuous variables will be investigated. In addition, a bivariate correlation analysis (ANOVA) will be performed. The significance level will be 0.05.
Expected Results It will provide updated evidence in the field of assessing the state of spastic muscles in subjects with neurological damage, a situation that will guide the therapeutic process and may improve the patient's prognosis and quality of life.
详细描述
Background: Spasticity is considered a positive clinical sign of upper motor neuron damage, associated with prevalent neurological pathologies such as stroke, constituting a clinical characteristic with a high incidence in the field of neurorehabilitation.
General Objective To describe the morphological characteristics of spastic biceps brachii and triceps surae muscles, using ultrasound examination, in subjects who have suffered a stroke.
Specific Objectives
- Identify the morphological characteristics of the biceps, using ultrasound examination, in subjects after stroke.
- Identify the morphological characteristics of the triceps surae, using ultrasound examination, in subjects after stroke.
- Correlate the morphological characteristics of the biceps and triceps surae with the values obtained on the Ashworth and Tardieu scales.
- Correlate the morphological characteristics of the biceps and triceps surae with the time of evolution and type of stroke.
Procedure
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients over 18 years of age with a history of stroke more than three months ago.
- •Who are undergoing or have undergone some type of rehabilitation in the acute and/or subacute stage.
- •Who present spastic hypertonia in the upper and lower extremities detectable by Ashworth and Tardieu assessment.
- •Presence of spastic pattern according to Hefter classification.
- •Who agree to participate in the study and sign the consent form.
排除标准
- •Structural joint involvement that prevents tone assessment.
- •Patients who have been injected with antispastic drugs in the last 6 months.
结局指标
主要结局
Spasticity
时间窗: Outcome measure: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.
Modified Ashworth Scale (MAS) The scale measures resistance during passive soft-tissue stretching. Lower values mean less spasticity Scoring: 0 - No increase in muscle tone. 1 - Slight increase in muscle tone, manifested by a catch and release at the end of the range of motion when the affected part(s) are moved in flexion or extension. 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2 - More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved. 3 - Considerable increase in muscle tone, passive movement difficult. 4 - Affected part(s) rigid in flexion or extension.
Spasticity
时间窗: Outcome measure: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.
Modified Ashworth Scale (MAS) The scale measures resistance during passive soft-tissue stretching. Lower values mean less spasticity Scoring: 0 - No increase in muscle tone. 1 - Slight increase in muscle tone, manifested by a catch and release at the end of the range of motion when the affected part(s) are moved in flexion or extension. 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2 - More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved. 3 - Considerable increase in muscle tone, passive movement difficult. 4 - Affected part(s) rigid in flexion or extension.
次要结局
- Spasticity(Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.)
- Morphological characteristics(Day 1, after the initial assessment. 5 patients per day, completing 15 per week at each center. Total intervention time, through study completion, an average of 6 months.)
- Spasticity(Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.)
- Morphological characteristics(Day 1, after the initial assessment. 5 patients per day, completing 15 per week at each center. Total intervention time, through study completion, an average of 6 months.)
研究者
ARLETTE PATRICIA DOUSSOULIN SANHUEZA
Associate professor
Universidad de La Frontera