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临床试验/NCT03863678
NCT03863678已完成不适用

Effects of Dry Needling on Spasticity, Upper and Lower Extremity Functions, Balance and Independence Level in Addition to Neurodevelopmental Therapy in Patients With Stroke

Eastern Mediterranean University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Range of movement (ROM) measurement

研究概览

简要总结

The aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity.

详细描述

The aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity. In this study, goniometric measurement, Modified Ashworth Scale, Nine Hole Peg Test, 10 Meter Walking Test, Fullerton Advanced Balance Scale and Functional Independence Scale will be used for outcome measurement. The participants will be randomised into two groups; Group 1 will receive NDT and Group 2 will receive both NDT and dry needling therapy. Both groups will be given 45 minutes of NDT, 3 sessions per week in 4 weeks period (total of 12 sessions). Group 2 will also receive dry needling therapy 3 sessions per week in 4 weeks period (total of 12 sessions). Dry needling will be applied on M. Gastrocnemius, M.Quadriceps, M.Flexor Carpi Radialis and M.Biceps Brachii muscles. The application time on each muscle will be 60 seconds (sec). Fast in and fast out technique will be used for dry needling therapy. All patients will be measured before treatment (T1) and after treatment (T3). An inter-measurement will be performed after the treatment session (T2) in addition to T1 and T3 measurements in the Group 2, to evaluate the acute effects of dry needling therapy. No additional treatment will be applied to the Group 1. All assessments will be performed by the same physiotherapist.

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
None

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

  • First time stroke,
  • Patients who has spasticity due to stroke,
  • At least 6 months after stroke,
  • Individuals between the ages of 18-75 will be included in the study.

排除标准

  • Any contraindication for dry needling (eg, anticoagulants, infections, bleeding, etc.),
  • Having diabetes,
  • Having cardiovascular diseases,
  • Having any other neurological problems,
  • Application of Botox within 6 months prior to the study,
  • Individuals included in another treatment program will not be included in the study.

结局指标

主要结局

Range of movement (ROM) measurement

时间窗: Change from baseline ROM measurement at 4 weeks

Measurement of joint movement of individuals will be done by a goniometer by the same physiotherapist. First passive normal joint movement then active normal joint movement will be evaluated and recorded.

Modified Ashworth Scale (MAS)

时间窗: At the baseline and at the end of 4 weeks

Modified ashworth scale (MAS) will be used to evaluate the spasticity of upper (elbow flexors flexor carpi radialis) and lower (quadriceps and gastrocnemius) extremity muscles. The MAS assess the level of spasticity on ordinal scale from 0 to 4 based on the level of resistance in response to a quick and passive movement. According to the MAS scale, 0 represents no increase in muscle tone, 1 represents slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension, 1+ represents increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2 represents more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3 represents considerable increase in muscle tone, passive movement difficult and 4 represents affected part(s) rigid in flexion or extension.

次要结局

  • 10 Meter Walking Test(At the baseline and at the end of 4 weeks)
  • Nine Hole Peg Test(At the baseline and at the end of 4 weeks)
  • Fullerton Advanced Balance Scale(At the baseline and at the end of 4 weeks)
  • Functional Independence Scale(At the baseline and at the end of 4 weeks)

研究者

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

Kübra Küçüktepe

Msc Physiotherapist

Eastern Mediterranean University

研究点 (2)

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