Clinical trial NCT03377712: Surgical Repercussions in Respiratory System in Patients With Post-Traumatic Brachial Plexus Injuries: A Prospective Cohort Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Injury
Respiratory Evaluation
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be composed of patients diagnosed with traumatic injury of the brachial plexus, at most one year of injury after the accident, confirmed by electromyography (ENMG), and who will undergo surgical intervention. The patients will be screened at the main reference center in Pernambuco, Recife Hospital / Recife

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.

Eligibility criteria: Inclusion Criteria Patients who will undergo surgical intervention; male; between 20 and 45 years of age; sedentary.

Exclusion Criteria Pulmonary contusions; Severe pneumopathies; Diabetes mellitus; Coronary artery disease; Multiple thorax fractures; Amputation of one limb; Cognitive changes

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Primary outcomes:
measure: thoracoabdominal kinematics
timeFrame: There will be two evaluations: one evaluation before surgery, another after six month
measure: mobility diaphragmatic
timeFrame: There will be two evaluations: one evaluation before surgery, another after six month
Secondary outcomes:
measure: Postural evaluation
timeFrame: There will be two evaluations: one evaluation before surgery, another after six month
measure: Pain
timeFrame: There will be two evaluations: one evaluation before surgery, another after six month
measure: Evaluation of the function
timeFrame: There will be two evaluations: one evaluation before surgery, another after six month
measure: Functional capacity assessment
timeFrame: There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery
measure: Quality of life assessment
timeFrame: There will be two evaluations: one evaluation before surgery, another after six month
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Helen Fuzari
state: PE
Study officials:
References: