跳至主要内容
临床试验/NCT03377712
NCT03377712已完成不适用

SURGICAL REPERCUSSIONS IN RESPIRATORY SYSTEM, TRUNK BIOMECHANICAL, FUNCTIONAL CAPACITY AND QUALITY OF LIFE IN PATIENTS WITH POST-TRAUMATIC BRACHIAL PLEXUS INJURIES: A PROSPECTIVE COHORT STUDY

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月2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
20
试验地点
1
主要终点
thoracoabdominal kinematics

研究概览

简要总结

To evaluate the surgical repercussions in patients with traumatic brachial plexus injury in the respiratory and motor systems, trunk biomechanics, functional capacity and quality of life.

详细描述

Type of study will be a prospective cohort. The study will be performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco (UFPE). The sample will be calculated from a pilot study to be previously performed. The pilot study should have 10 individuals, 5 patients in each of the two groups. A group of patients who has brachial plexus injury and a group of healthy individuals for the pairing by sex and age. Eligibility criteria: patients who will undergo surgical intervention (within one year of the trauma), of both sexes, between 20 and 45 years of age, sedentary (oriented and encouraged to perform the activities of daily living at home, however , outside of any rehabilitation program) and encouraged to refrain from using tobacco. Patients with pulmonary contusions, severe pneumopathies, patients with congestive heart failure (NYHA class III or IV), diabetes mellitus, coronary artery disease, hemodynamic instability (MAP <60 mmHg), multiple thorax fractures, amputation of one limb cognitive changes. Physiotherapeutic evaluations will be performed by a single physiotherapist trained in the preoperative one, three and six months after surgery for brachial plexus injury. The instruments of evaluation included are: optoelectronic plethysmography, spirometry, manovacuometry, diaphragmatic ultrasound, g-walk, upper limb dynamometry, pain questionnaires (Mcgill and DN4), upper limb functionality questionnaire (DASH) minutes and the quality of life questionnaire (Whoquol). Expected Results: The greatest impact should be to assist the patient in the prevention and physiotherapeutic treatment in relation to the possible sequels arising from the surgical process, besides fomenting the literature, expanding the knowledge about the subject and determining the applicability of the existing therapeutic resources, so that these are not used indiscriminately in daily practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

thoracoabdominal kinematics

时间窗: There will be two evaluations: one evaluation before surgery, another after six month

It will be evaluated through optoelectronic plethysmography

mobility diaphragmatic

时间窗: There will be two evaluations: one evaluation before surgery, another after six month

It will be evaluated by means of an ultrasound

次要结局

  • Evaluation of the function(There will be two evaluations: one evaluation before surgery, another after six month)
  • Postural evaluation(There will be two evaluations: one evaluation before surgery, another after six month)
  • Pain(There will be two evaluations: one evaluation before surgery, another after six month)
  • Functional capacity assessment(There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery)
  • Quality of life assessment(There will be two evaluations: one evaluation before surgery, another after six month)

研究者

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

Helen Fisio

Doctor student

Universidade Federal de Pernambuco

研究点 (1)

Loading locations...

相似试验