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临床试验/NCT04237415
NCT04237415已完成不适用

The Effect of Electromyographic (EMG) Biofeedback Training on Electrical Muscle Activity and Functional Status in Zone I-III Flexor Tendon Injuries

Pamukkale University0 个研究点目标入组 22 人开始时间: 2016年10月10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
22
主要终点
Finger joint range of motion

研究概览

简要总结

Aim: The aim of the study was to investigate the effect of electromyographic (EMG) biofeedback training applied in addition to early passive motion protocol on electrical muscle activity (EMA) and functional status in zone I-III flexor tendon injuries.

Materials and Methods: Cases who underwent surgery for flexor tendon injuries in zone I-III were included in this prospective randomized controlled trial. Cases were randomly divided into two groups of 11 cases each by block randomization. In the first group, EMG biofeedback training was applied in addition to the early passive motion method (modified Duran protocol), while the second group was followed only by early passive motion method. The treatment program was performed by the same physiotherapist three times a week, for 12 weeks. At the postoperative 5th, 12th and 24th weeks, joint range of motion (ROM) and EMA were evaluated, and the Michigan Hand Outcome Questionnaire (MHQ) was administered to the patients. The grip strength at 12th and 24th weeks were also assessed. The Mann-Whitney U Test was used to compare the two groups.

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 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being olunteer,
  • No history of neurological, orthopedic, rheumatologic disease or trauma in the related extremity,
  • No history of neuropathy due to a metabolic disease (diabetes, etc.),
  • Incision of at least one of the FDS or FDP tendons,
  • At least one of the FDS or FDP tendons repaired within 2 weeks after the injury,
  • No communication problems.

排除标准

  • <18 years of age,
  • Pregnancy,
  • Thumb flexor tendon cuts,
  • Digital nerve injury,
  • Accompanying fracture, joint capsule injury or skin loss,
  • Crush injury,
  • Patients with pacemakers,
  • Patients with cardiac arrhythmias,
  • Epilepsy.

结局指标

主要结局

Finger joint range of motion

时间窗: 24th week

Finger motion was measured by goniometer.Total active motion protocol was used.

Electrical muscle activity

时间窗: 24th week

Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.

Grip strength

时间窗: 24th week

Gross and pinch strength were evaluated by hand dynamometer.

Michigan Hand Questionnaire

时间窗: 24th week

This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.

次要结局

未报告次要终点

研究者

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

UMUT ERASLAN

Research Assistant

Pamukkale University

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