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临床试验/NCT02974465
NCT02974465已完成不适用

Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial

University of Alcala0 个研究点目标入组 40 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
Fugl-Meyer Upper-Extremity Scale (FMA-UE)

研究概览

简要总结

The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper limb hemiparesis added to conventional physical therapy on changes in upper extremity functionality, motor recruitment pattern and range of motion (ROM) compared to the single application of conventional physical therapy. It aims to find a 22.22% difference between both interventions.

详细描述

Upper limb hemiparesis is a common consequence after brain damage.

Objective: To evaluate the effect of a specific protocol of surface electromyographic biofeedback (sEMG-BFB) and conventional physical therapy in upper limb functionality, muscle recruitment changes, and glenohumeral range of motion compared to the single application of conventional physical therapy.

Design: randomized controlled clinical trial.

Sample: 40 participants from State Center of Attention to Brain Injury were recruited.

Interventions: Patients were randomly assigned to 2 groups where the experimental group received sEMG-BFB for the upper trapezius and middle deltoid muscles of the upper limb with hemiparesis and the control group received a placebo of the same technique. Both treatments were applied for 6 weeks. The score of the Fugl-Meyer Assessment-Upper Extremity" for functionality and shoulder range of motion were objectified. Root mean square (RMS) value was assessed as a secondary measure Data were collected before and after intervention.

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
15 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • acquired brain injury after two months of medical evolution at least;
  • suffer paretic upper limb;
  • spasticity no greater than 3 in the modified Ashworth scale;
  • minimum active ROM of 20º of glenohumeral abduction.

排除标准

  • peripheral nerve injury, fractures of upper limb, cervical radiculopathy, complete luxation of the shoulder and severe cognitive impairment.

研究组 & 干预措施

Experimental Group

Experimental

protocol of Biofeedback Electromyography plus conventional physical therapy treatment

干预措施: Biofeedback Electromyography (Procedure)

Experimental Group

Experimental

protocol of Biofeedback Electromyography plus conventional physical therapy treatment

干预措施: Conventional Physical Therapy Treatment (Procedure)

Control Group

Sham Comparator

consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment

干预措施: Sham Biofeedback Electromyography (Procedure)

Control Group

Sham Comparator

consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment

干预措施: Conventional Physical Therapy Treatment (Procedure)

结局指标

主要结局

Fugl-Meyer Upper-Extremity Scale (FMA-UE)

时间窗: 15 minutes

Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury

次要结局

  • range of motion(10 minutes)

研究者

发起方
University of Alcala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Lirio Romero

Physiotherapist

University of Alcala

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