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

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ClinicalTrials.gov Identifier: NCT03377712
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Helen Fisio, 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.

Condition or disease Intervention/treatment
Brachial Plexus Injury Respiratory Evaluation Device: optoelectronic plethysmography Device: diaphragmatic ultrasound Device: Postural evaluation Device: Pain evaluation Device: Evaluation of the function Device: Functional capacity assessment Device: Quality of life assessment

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : March 26, 2019

Group/Cohort Intervention/treatment
Brachial Plexus Injury group
Patients who will be submitted to the surgical procedure and monitored for the repercussions of the surgery. Interventions: optoelectronic plethysmography, diaphragmatic ultrasound, postural evaluation, functional capacity, pain evaluation, function and quality of life
Device: optoelectronic plethysmography
Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations

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

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

Device: Pain evaluation
by means of questionnaires

Device: Evaluation of the function
through questionnaires

Device: Functional capacity assessment
Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment

Device: Quality of life assessment
through questionnaire

Paired group
Healthy individuals who will be matched by sex and age with the group of patients who will effectively undergo the surgical process. Interventions: optoelectronic plethysmography, diaphragmatic ultrasound, postural evaluation and functional capacity.
Device: optoelectronic plethysmography
Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377712


Locations
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Brazil
Helen Fuzari
Recife, PE, Brazil, 51021-360
Sponsors and Collaborators
Universidade Federal de Pernambuco
Additional Information:

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Responsible Party: Helen Fisio, Doctor student, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03377712    
Other Study ID Numbers: UFPE POSNEURO
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries