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

April 15, 2019 updated by: Helen Fisio, Universidade Federal de Pernambuco

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PE
      • Recife, PE, Brazil, 51021-360
        • Helen Fuzari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
thoracoabdominal kinematics
Time Frame: There will be two evaluations: one evaluation before surgery, another after six month
It will be evaluated through optoelectronic plethysmography
There will be two evaluations: one evaluation before surgery, another after six month
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
There will be two evaluations: one evaluation before surgery, another after six month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
There will be two evaluations: one evaluation before surgery, another after six month
Pain
Time Frame: There will be two evaluations: one evaluation before surgery, another after six month
evaluation by means of questionnaire
There will be two evaluations: one evaluation before surgery, another after six month
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).
There will be two evaluations: one evaluation before surgery, another after six month
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
There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery
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.
There will be two evaluations: one evaluation before surgery, another after six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFPE POSNEURO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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