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Completed

NCT Number: NCT03377712

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

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.

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Key information

Conditions

Brachial Plexus Injury Respiratory Evaluation

Age range

20 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Helen Fuzari

Recife, Pernambuco, 51021-360, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

optoelectronic plethysmography

Device

Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations

diaphragmatic ultrasound

Device

Evaluates the diaphragmatic mobility through images, simple and non-invasive use

Postural evaluation

Device

Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive

Pain evaluation

Device

by means of questionnaires

Evaluation of the function

Device

through questionnaires

Functional capacity assessment

Device

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

Device

through questionnaire

Primary outcomes

  1. thoracoabdominal kinematics

    Time frame: There will be two evaluations: one evaluation before surgery, another after six month

    It will be evaluated through optoelectronic plethysmography

  2. mobility diaphragmatic

    Time frame: There will be two evaluations: one evaluation before surgery, another after six month

    It will be evaluated by means of an ultrasound

Secondary outcomes

  1. Postural evaluation

    Time frame: 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

  2. Pain

    Time frame: There will be two evaluations: one evaluation before surgery, another after six month

    evaluation by means of questionnaire

  3. Evaluation of the function

    Time frame: 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).

  4. Functional capacity assessment

    Time frame: 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

  5. Quality of life assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 19, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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