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临床试验/NCT04775511
NCT04775511Unknown不适用

Clinical and Ultrasonographic Comparison of the Effect of Hot and Cold Therapy on Spasticity

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Medial gastrokinemius muscle via ultrasonographic measurement

研究概览

简要总结

Spasticity is a positive sign of upper motor neuron syndrome. The frequency of spasticity development in patients with stroke is 38%. Spasticity is one of the important factors that negatively affect the rehabilitation potential and functional recovery of the patient. In the treatment of spasticity, oral antispasticide drugs, phenol, ethyl alcohol, botulinum toxin, and chemical nerve and motor point blocks, physical therapy, and rehabilitation, surgical methods are used. In the physical therapy rehabilitation program of spasticity, stretching and strengthening exercises, cold application, warm application, ultrasound therapy, electrical stimulation, biofeedback, extracorporeal shock therapy are used. Stretching exercises are the cornerstone of spasticity treatment. In many clinical and experimental studies, a decrease in spasticity has been noted after stretching exercises. It has been stated that the application of cold or hot applications before stretching may increase the effectiveness of spasticity treatment. The study comparing the effectiveness of hot and cold treatment applied before stretching exercises clinically and ultrasonographically has not been found in the literature. The purpose of this study is the evaluation of clinical and ultrasonographic comparison of the effect of hot and cold treatment on spasticity before stretching exercises in patients with stroke. This study is unique because it is the first study that evaluates the effect of hot and cold applications on spasticity before the stretching.

详细描述

The study is a randomized and controlled study. 30 patients will be included to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of spasticity after stroke, aged between 18-75 years. These patients will be divided in three groups randomly (group1 n:10, group 2 n:10, group 3 n:10).

First group: 20 minutes of hot pack application to the medial gastrocnemius muscle. Then the patient will do stretching exercises to the gastrocnemius muscle, which will be done for 20 minutes. In hot pack for hot application; While the patient is lying in a prone position, a warm package, a towel between the skin and the skin will be applied on the gastrocnemius muscle and applied for 20 minutes.

Second group: 20 minutes to apply a cold pack to the medial gastrocnemius muscle, followed by stretching the patient for 20 minutes to the gastrocnemius muscle. The cold pack is available for cold application; While the patient is lying in a prone position, a cold pack will be placed on the gastrocnemius muscle, and a towel will be applied for 20 minutes.

Third group: 20 minutes of stretching and stretching exercises will be applied.

In stretching exercises, stretching will be done for 30 seconds. The stretching exercise will be performed by the same physiotherapist with maximal tension to the ankle in the supine position of the patient in the hip and knee extension.

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 (Participant)

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

入选标准

  • Being first stroke attack
  • Grade ≥1 Spasticity in the medial gastrocnemius muscle according to modified ashwort scale
  • At least 6 weeks have passed since the stroke

排除标准

  • Antispasticidal drug use
  • Botulinum toxin injection into the gastrocnemius muscle
  • Having another nervous system or orthopedic disease that can affect measurements

结局指标

主要结局

Medial gastrokinemius muscle via ultrasonographic measurement

时间窗: All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.

Change of the medial gastrocinemius pennat angle, medial muscle fascicule length, achilles tendon length

次要结局

  • Change of the ankle range of motion(All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.)
  • Change of the degree of spastisity(All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Banu Dilek

Assoc Prof

Dokuz Eylul University

研究点 (1)

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