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临床试验/CTRI/2024/03/064110
CTRI/2024/03/064110尚未招募3 期

Effect of extracorporeal shockwave therapy on spasticity in chronic stroke patients

Sariya Azam1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月24日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To reduce spasticity

研究概览

简要总结

the phenomenon of spasticity following a stroke and Extracorporeal Shockwave Therapy (ESWT) as a potential treatment option for reducing spasticity in stroke patients. Spasticity is described as a motor disorder resulting from hyperexcitability of the stretch reflex, contributing to functional limitations and negatively impacting recovery.

ESWT is a series of high-energy mechanical waves with characteristics such as pressure, rapid pressure increase, and short action cycle. It is categorised into focused (fESWT) and radial (rESWT) types, each having different penetration depths and applications. The study emphasises ESWT’s ability to induce nitric oxide synthesis, reduce motor neuron excitability, modulate nerve conduction, and affect muscle and soft tissue.

Several studies and findings are referenced to support the claim that ESWT may alleviate limb spasticity after a stroke through mechanisms such as increased nitric oxide production, reduced motor neuron excitability, and modulation of nerve conduction. The text also mentions the impact of ESWT on muscle and soft tissue, suggesting improvements in joint mobility and muscle properties.

The need for further research on the effects of shockwave therapy on spasticity in stroke patients is highlighted. The potential benefits include offering an alternative treatment option, a non-invasive approach, and potentially improving rehabilitation outcomes for stroke survivors.

The study’s aim is stated as determining whether shockwave therapy can effectively reduce spasticity in chronic stroke patients. The objective is to examine if stroke patients receiving shockwave therapy show better mobility and functional capacities, with specific measurements of muscle tone and range of motion. Two hypotheses are presented: a null hypothesis suggesting no significant difference in spasticity reduction with shockwave therapy and an alternate hypothesis proposing a statistically significant difference.

Inclusion criteria for potential study participants are outlined, including a history of stroke, a specified age range, medical stability, presence of spasticity, and willingness to engage in shockwave therapy. Exclusion criteria involve severe cognitive impairments, uncontrolled medical conditions, pre-existing shoulder injuries or surgeries, inability to provide informed consent, and participation in conflicting rehabilitation programs.

The dependent variable in the study is the level of spasticity, while the independent variable is the application of extracorporeal shockwave therapy. The text suggests using the Modified Ashworth Scale and possibly other tools to measure and evaluate the effects of shockwave therapy on spasticity.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Individuals who have experienced a stroke.
  • Age range (e.g., 30-75 years old).
  • Medically stable participants.
  • Presence of spasticity.
  • Participants willing to engage in extracorporeal shockwave therapy.

排除标准

  • Severe cognitive impairments that hinder participation.
  • Uncontrolled medical conditions.
  • Pre-existing shoulder injuries or surgeries.
  • Inability to provide informed consent.
  • Participation in other conflicting rehabilitation programs.

结局指标

主要结局

To reduce spasticity

时间窗: 8 weeks

次要结局

  • To increase range of motion and improve quality of life(8 weeks)

研究者

发起方
Sariya Azam
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

SARIYA AZAM

Amity Institute of health allied sciences

研究点 (1)

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