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临床试验/NCT06225024
NCT06225024已完成不适用

Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) Following Botulinum Toxin Type A Injection on Post-Stroke Ankle Plantar Flexor Spasticity

Kayseri City Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Modified Ashworth Scale (MAS)

研究概览

简要总结

Introduction: We aimed to compare the efficacy of Botulinum Toxin Type A(BoNT-A) injection and BoNT-A injection in combination with ESWT for post-stroke lower extremity ankle plantar flexor spasticity.

Materials and Method: Patients with post-stroke ankle plantar flexor spasticity of 1 or more on the modified Ashworth Scale(MAS) were randomized into two groups.

Group 1(n:20): BoNT-A was injected into the gastrocnemius muscle and conventional physical therapy exercises were performed.

Group 2(n:20): ESWT was applied to the gastrocnemius muscle in addition to the treatments in group 1.

详细描述

Group 1 (n:20): BoNT-A was injected into the affected gastrocnemius muscle under ultrasonography guidance at doses recommended by standard guidelines and appropriate for the patient (50 IU to the medial head, 25 IU to the lateral head). In addition, conventional physical therapy exercises (stretching exercises, range of motion (ROM) exercises, neurophysiologic exercises, and gait exercises) were applied to the patients five days a week for four weeks.

Group 2 (n:20): In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle.

The patients in both groups underwent the following evaluations before treatment, at one month and three months after treatment by a treatment-blinded Physical Medicine and Rehabilitation (PMR) physician.

Patients' age, sex, occupation, hemiplegic sides, and etiology of hemiplegia were recorded. Physical examination was performed, and examination findings were recorded. The presence of post-treatment pain, redness, tenderness, or other adverse findings were questioned.

MAS, Brunnstrom Motor Recovery Stage(BMRS), ankle range of motion(ROM) measurement, clonus score(CS), Barthel Index(BI), Heckmatt measurements with ultrasonography, and visual analog scale(VAS) evaluations were performed on the patients.

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
Single (Outcomes Assessor)

盲法说明

The patients in both groups underwent the following evaluations before treatment, at one month and three months after treatment by a treatment-blinded Physical Medicine and Rehabilitation (PMR) physician:

  1. Modified Ashworth Scale (MAS)
  2. Brunnstrom Motor Recovery Stage (BMRS)
  3. Ankle range of motion (2) measurement
  4. Clonus score (CS)
  5. Barthel Index (BI)
  6. Heckmatt measurements with ultrasonography
  7. Visual analog scale (VAS) pain assessment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

BoNT-A

Active Comparator

BoNT-A was injected into the affected gastrocnemius muscle under ultrasonography guidance at doses recommended by standard guidelines and appropriate for the patient (50 IU to the medial head, 25 IU to the lateral head). In addition, conventional physical therapy exercises (stretching exercises, range of motion (ROM) exercises, neurophysiologic exercises, and gait exercises) were applied to the patients five days a week for four weeks.

干预措施: BoNT A (Drug)

BoNT-A and ESWT

Experimental

In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle.

干预措施: ESWT (Device)

BoNT-A and ESWT

Experimental

In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle.

干预措施: BoNT A (Drug)

结局指标

主要结局

Modified Ashworth Scale (MAS)

时间窗: at baseline, at one month and three months after treatment

This scale is used to evaluate the severity of spasticity. MAS is based on a subjective evaluation of the resistance felt during the examination. 0: No tone increase 1. Slight increase in tone characterized by a catch and release or minimal resistance at the end of the range of motion 1+: Slight increase in muscle tone with minimal resistance throughout less than half of the range of motion 2. Increased muscle tone throughout the entire range of motion, but joints can be easily moved 3. Considerable increase in tone; passive movement is difficult 4. Affected parts are rigid in flexion and extension.

次要结局

  • Brunnstrom Motor Recovery Stage (BMRS)(at baseline, at one month and three months after treatment)

研究者

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Havva Talay Çalış

Prof

Kayseri City Hospital

研究点 (1)

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