Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation; Prospective, Randomized, Controlled, Single-Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Upper Extremity Motor Rating Scale
研究概览
简要总结
In this study, it was aimed to evaluate whether or not NMES in front of the mirror brings an additional benefit to mirror therapy alone or NMES alone on upper extremity motor and functional development, spasticity, anxiety, depression, cognitive function and activities of daily living, and neuropathic pain.
详细描述
Cerebrovascular diseases are the general name given to clinical neurological pictures that occur as a result of pathological changes in the blood vessels of the primary lesion and / or in the properties of the blood passing through them. Many complications develop in the acute and chronic periods in patients with stroke, and the rate of complication development has been reported to vary between 40-96% in different studies. The aim of hemiplegic upper extremity rehabilitation is to prevent complications and improve lost motor-sensory control. Upper limb rehabilitation is less successful than lower limb rehabilitation because the upper limb is more functional and more complex.
For muscle reeducation, NMES is used to strengthen inhibited muscle groups, facilitate voluntary isolated muscle contraction, prevent muscle atrophy, increase metabolism and enzyme activity, change the contractile properties of the muscle, maintain or increase the normal range of motion of the joint, develop voluntary movement and functional gains. NMES has been used in hemiplegia rehabilitation since 1960 for the purpose of functional retraining of muscles. The purpose of this treatment is to enable the muscles with impaired neural function of the electrical current to perform a functional and useful movement.
Applications in front of the mirror are thought to trigger the neuronal connections in the motor cortex associated with the imagined movement. Findings obtained from studies with functional magnetic resonance support this theory. Compared to conventional PR, applications in front of the mirror are thought to have more and longer-lasting effects.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subacute hemiplegia
- •Patients who can communicate well, are motivated enough and are willing to participate in the study
- •Patients' medical conditions are stable
- •Initiation of voluntary extension movement in the wrist (lower limit)
排除标准
- •The presence of more than one previous cerebrovascular disease (except transient ischemic attack).
- •Presence of flaccid hemiplegia.
- •Presence of a previous neurological disease causing a decrease in strength in the affected extremity.
- •Presence of deformity due to a previous fracture, inflammatory arthropathy, etc. in the affected extremity.
- •Presence of more than grade 3 spasticity in upper extremity according to Modified Ashworth Scale
- •Use of cardiac pace maker
- •Presence of fatal cardiac arrhythmia
- •Presence of seizure history within 2 years.
研究组 & 干预措施
Group Mirror
Along with conventional rehabilitation techniques, patients will be given ROM exercises in all directions, in front of the real mirror, by the practitioner on the healthy upper extremity for 30 minutes.
干预措施: Group Mirror (Other)
Group NMES
Along with conventional rehabilitation techniques, NMES will be applied to the hemiplegic arm for 30 minutes by the practitioner while the patients are sitting in a chair.
干预措施: Group NMES (Device)
Group Mirror+NMES
In addition to conventional rehabilitation techniques, patients will be given ROM exercises for 30 minutes in all directions in front of the real mirror to the healthy extremity, which the practitioner will synchronize with visual or auditory stimuli, and NMES treatment for 30 minutes to the paretic upper extremity.
干预措施: Group Mirror+NMES (Other)
结局指标
主要结局
Fugl-Meyer Upper Extremity Motor Rating Scale
时间窗: Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week
To analysis the increase in upper limb motor function Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. Sensation: ranges from 0 to 24 points. Divided into 8 points for light touch and 16 points for position sense.
次要结局
- Brunnstrom stages(Change from Baseline Brunnstrom stages at 3rd week)
- Modified Tardieu Scale(Change from Baseline Modified Tardieu Scale at 3rd week)
- Functional Independence Scale (FIM)(Change from Baseline Functional Independence Scale (FIM) at 3rd week)
- Mini-Mental Test(Change from Baseline Mini-Mental Test at 3rd week)
- Pain Detect Questionnaire(Change from Baseline Pain Detect Questionnaire at 3rd week)
- Numeric Rating Scale(Change from Baseline Numeric Rating Scale at 3rd week)
研究者
Dr. Burcu Metin Ökmen
Principal Investigator
Bursa Yuksek Ihtisas Training and Research Hospital