Clinical Trials Directory

Trials / Completed

CompletedNCT03377712

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Universidade Federal de Pernambuco · Academic / Other
Sex
Male
Age
20 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEoptoelectronic plethysmographyEvaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations
DEVICEdiaphragmatic ultrasoundEvaluates the diaphragmatic mobility through images, simple and non-invasive use
DEVICEPostural evaluationEvaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive
DEVICEPain evaluationby means of questionnaires
DEVICEEvaluation of the functionthrough questionnaires
DEVICEFunctional capacity assessmentEvaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
DEVICEQuality of life assessmentthrough questionnaire

Timeline

Start date
2018-01-02
Primary completion
2018-12-21
Completion
2019-03-26
First posted
2017-12-19
Last updated
2019-04-16

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03377712. Inclusion in this directory is not an endorsement.