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临床试验/NCT06725069
NCT06725069已完成不适用

Effects of Neuromuscular Electrical Stimulation Applied to Agonist or Antagonist Muscles of the Upper Extremity on Flexor Spasticity and Function in Patients With Stroke

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
The Modified Ashworth Scale (MAS)

研究概览

简要总结

In this study, the investigators aimed to determine the effects of botulinum neurotoxin type A injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients.

详细描述

Neuromuscular electrical stimulation therapy applied to wrist and finger flexors (agonist application) or wrist and finger extensors (antagonist application) after botulinum neurotoxin type A injections in stroke patients with wrist and finger flexor spasticity in upper extremity flexor spasticity, To determine the effects on motor recovery, upper extremity and hand functions, hand grip strength, range of motion, functional independence, quality of life, hand skills and sonographically evaluated muscle thickness and to compare these different applications.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
  • First time stroke survivor
  • between 45-75 years old
  • Stroke duration > 3 months
  • Neurologically stable
  • Affected wrist and finger flexor muscle spasticity with MAS≥2
  • Patients whose cognitive status is at a level to understand the study instructions MMT> 23)

排除标准

  • Presence of another neurological disorder other than stroke causing motor impairment/spasticity
  • Fixed contracture in the hand-wrist
  • Use of medical treatment for spasticity
  • Having received neurolytic therapy, BoNT-A injection or NMES treatment in the last 3 months
  • Skin problem (disease, allergy, infection, etc.) on the contact surface of the NMES
  • Complex regional pain syndrome (CRPS), sequelae of previous trauma or surgery (muscle tendon adhesion, peripheral nerve damage) in the affected extremity
  • Having a pacemaker

结局指标

主要结局

The Modified Ashworth Scale (MAS)

时间窗: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

The Modified Ashworth Scale (MAS) is a clinical tool used to assess spasticity, which is characterized by increased muscle tone and resistance to passive movement. It is commonly applied in individuals with neurological conditions such as stroke, multiple sclerosis, or cerebral palsy. The scale involves passively moving a limb through its range of motion and evaluating the resistance felt. The scoring ranges from 0 to 4, where 0 indicates no increase in muscle tone, 1 represents a slight increase with a catch or minimal resistance at the end of the range, and 1+ reflects a catch followed by minimal resistance through less than half of the movement. A score of 2 denotes a more marked increase in tone through most of the range, but the limb remains movable. 3 indicates considerable resistance, making movement difficult, and 4 signifies a rigid limb with severe spasticity. This scale is widely used in rehabilitation to monitor spasticity and guide treatment interventions.

Brunnstrom

时间窗: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

The Brunnstrom Stages of Recovery describe the six stages of motor recovery following a stroke or brain injury. In Stage 1, there is flaccidity, with no voluntary movement or reflex activity in the affected limb. Stage 2 marks the beginning of spasticity, with the emergence of basic limb synergies and minimal voluntary movement. In Stage 3, spasticity reaches its peak, and voluntary control is limited to synergy patterns. Stage 4 involves a decrease in spasticity, with the appearance of some voluntary movements outside of synergy patterns. By Stage 5, spasticity continues to decline, and more complex and isolated movements become possible. Finally, in Stage 6, normal movement patterns are largely restored, with minimal or no spasticity and full control of isolated joint movements.

次要结局

未报告次要终点

研究者

发起方
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emrah Karaduman

Resident Doctor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

研究点 (1)

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