Effectiveness of Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Spasticity grade change
研究概览
简要总结
This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.
详细描述
The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect.
The stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs.
Additional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.
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
- Double (Participant, Outcomes Assessor)
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
- •a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;
- •no history of previous stroke;
- •lower limb post-stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
- •pain intensity measured on Visual Analogue Scale (VAS) ≥1;
- •ability to stand unassisted in upright position for 30 seconds;
- •no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale
- •adult patients (>18 years old)
排除标准
- •other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;
- •myopathies;
- •severe cognitive impairment, severe aphasia or inability to understand instructions;
- •severe spasticity;
- •visual field conditions or hemineglect;
- •patients unable to undergo follow-up evaluation and excluded from the final analysis;
- •anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.
结局指标
主要结局
Spasticity grade change
时间窗: Change from baseline Modified Ashworth Scale at 14 days
The Modified Ashworth Scale (MAS)
次要结局
- Pain intensity change(Change from baseline Visual Analogue Scale at 14 days)
- Range of motion change(Change from baseline Passive Range of Motion at 14 days)
- Stabilometric outcomes change(Change from baseline Prokin system parameters at 14 days)
研究者
Emanuela Elena Mihai
Principal Investigator
Carol Davila University of Medicine and Pharmacy