Retrospective Evaluation of Muscle Selection, Dosage, and Clinical Outcomes in Botulinum Toxin Applications in Hemiplegic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Spasticity Severity:
研究概览
简要总结
This retrospective study will be conducted by reviewing the medical records of hemiplegic patients who received botulinum toxin treatment between 2017 and 2020 at the Physical Medicine and Rehabilitation outpatient clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. A total of 35 hemiplegic patients who underwent botulinum toxin injection and had at least two follow-up records (with a 6-month interval) will be included. Sociodemographic and clinical data, stroke-related characteristics, botulinum toxin dosage, injected muscle groups, medications, and comorbidities will be recorded. Functional assessments, including the Functional Independence Measure (FIM) and Brunnstrom stage, as well as spasticity evaluations using the Modified Ashworth Scale and the Global Spasticity Index, will be obtained from patient files.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years, clinically diagnosed with hemiplegia
- •Received botulinum toxin injection for upper and/or lower extremity spasticity
- •Availability of recorded data for two time points, including the Functional Independence Measure (FIM), Brunnstrom stage, Modified Ashworth Scale (MAS), Global Spasticity Index (GSI)
- •Documentation of injected muscles and total administered botulinum toxin dosage
排除标准
- •Missing essential data (e.g., absence of FIM, MAS, GSI, or GAS at either visit)
- •Major interventions during the follow-up period such as surgery or initiation of intrathecal baclofen pump therapy
- •Severe concomitant neurological disorders (e.g., progressive neurodegenerative diseases) that interfere with assessment
结局指标
主要结局
Change in Spasticity Severity:
时间窗: Baseline
Evaluated using the Modified Ashworth Scale (MAS) before and after botulinum toxin treatment. A decrease in MAS scores indicates a reduction in muscle tone and improved spasticity control.
次要结局
- Functional Independence Measure (FIM):(Baseline)
- Injected Muscle Groups and Dosage:(Baseline)
- Global Spasticity Index (GSI):(Baseline)
- Brunnstrom Stage:(Baseline)