Surgical Repercussions in Respiratory System in Patients With Post-Traumatic Brachial Plexus Injuries: A Prospective Cohort Study

Completed

• Conditions: Brachial Plexus Injury; Respiratory Evaluation

• Registration Number: NCT03377712
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-19
• Study Start: 2018-01-02
• Primary Completion: 2018-12-21
• Study Completion: 2019-03-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thoracoabdominal kinematics	There will be two evaluations: one evaluation before surgery, another after six month	It will be evaluated through optoelectronic plethysmography
mobility diaphragmatic	There will be two evaluations: one evaluation before surgery, another after six month	It will be evaluated by means of an ultrasound

Secondary Outcome Measures

Name	Time	Method
Evaluation of the function	There will be two evaluations: one evaluation before surgery, another after six month	through questionnaire - Arm, Shoulder and Hand Disability (DASH). The score is given by a formula: Sum of the first 30 questions, subtract 30 and then divide by 1.2 The higher the score, the worse the function of the upper limbs (always evaluating the two limbs at the same time).
Postural evaluation	There will be two evaluations: one evaluation before surgery, another after six month	evaluates the patient's posture through photos, rapid examination, simple and non-invasive. Only the registration of images will be reactivated
Pain	There will be two evaluations: one evaluation before surgery, another after six month	evaluation by means of questionnaire
Functional capacity assessment	There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery	Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
Quality of life assessment	There will be two evaluations: one evaluation before surgery, another after six month	through questionnaire - World Health Organization Quality of Life Instrument (WHOQOL-Brief) - DOMAINS: Physical, Psychological, Social Relations, Environment and Self-evaluation of QOL. Score the higher the score, the better the quality of life of the patient.

Trial Locations

Locations (1)

Helen Fuzari; 🇧🇷 Recife, PE, Brazil