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临床试验/NCT04887376
NCT04887376已完成不适用

Additive Effect of Mirror Therapy on Effects of Cross-Education of Muscle Strength of Neuromuscular Electrical Stimulation In Hemiplegic Patients

Istanbul Physical Medicine Rehabilitation Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020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
29
试验地点
2
主要终点
Change of ankle dorsiflexor isometric muscle strength

研究概览

简要总结

This study was conducted to determine whether mirror therapy has an additive effect on cross-education of the strength of neuromuscular electrical stimulation (NMES) in patients with hemiplegia. As an outcome measure, the ankle dorsiflexion strength of hemiplegic patients was measured.

详细描述

A total of 29 patients, 7 women, and 22 men were included according to the inclusion and exclusion criteria. The patients were randomly assigned to the control group (n = 14) and the Mirror group (n = 15). Five sessions of neuromuscular electrical stimulation, unaffected side ankle dorsiflexors were applied to the patients in both groups. In addition to the NMES, mirror therapy was applied to the experimental group simultaneously with NMES. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.

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
Double (Participant, Outcomes Assessor)

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

  • Cases with stroke duration ≥ 1 month
  • Ability to walk at least 10m (functional ambulation scale ≥3)
  • Age range 18-75 years
  • Hemorrhagic or ischemic stroke
  • Brunnstrom stage ≥4 for lower limb
  • Unilateral stroke
  • Cooperating with the examination and tests

排除标准

  • Mini Mental State Assessment score <21
  • Severe spasticity (MAS = 4) in ankle dorsiflexors
  • Have a contracture on ankle joint
  • The presence of skin lesions in the application area
  • Painful pathologies in the lower extremities
  • Having visual field defects
  • Active inflammatory, rheumatological or infectious disease
  • Parent rhythm / conduction block problem in the heart
  • Uncontrollable hypertension (Maxima> 140, Minima> 90)
  • Presence of lower extremity fracture
  • Peripheral nerve lesions such as polyneuropathy, radiculopathy
  • Finding or suspected active deep vein thrombosis
  • History of deep vein thrombosis and pulmonary embolism

结局指标

主要结局

Change of ankle dorsiflexor isometric muscle strength

时间窗: Change from Baseline muscle strength at 6 days

Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force

次要结局

  • Change of Lower Extremity Brunnstrom score(Change from Baseline Brunnstrom score at 6 days)
  • Change of Functional Ambulation Scale score(Change from Baseline Functional Ambulation Scale score at 6 days)
  • Change of Modified Ashworth Scale score(Change from Baseline Modified Ashworth Scale score at 6 days)
  • Change of Timed Up and Go Test score(Change from Baseline Timed Up and Go Test score at 6 days)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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