- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03377712
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
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PE
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Recife, PE, Brazil, 51021-360
- Helen Fuzari
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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
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
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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 |
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
|
Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations
Evaluates the diaphragmatic mobility through images, simple and non-invasive use
Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive
by means of questionnaires
through questionnaires
Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe 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.
|
Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations
Evaluates the diaphragmatic mobility through images, simple and non-invasive use
Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive
|
What is the study measuring?
Primary Outcome Measures
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
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There will be two evaluations: one evaluation before surgery, another after six month
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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
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There will be two evaluations: one evaluation before surgery, another after six month
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Secondary Outcome Measures
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
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There will be two evaluations: one evaluation before surgery, another after six month
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Pain
Time Frame: There will be two evaluations: one evaluation before surgery, another after six month
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evaluation by means of questionnaire
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There will be two evaluations: one evaluation before surgery, another after six month
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Evaluation of the function
Time Frame: There will be two evaluations: one evaluation before surgery, another after six month
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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).
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There will be two evaluations: one evaluation before surgery, another after six month
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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
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Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
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There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery
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Quality of life assessment
Time Frame: There will be two evaluations: one evaluation before surgery, another after six month
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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.
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There will be two evaluations: one evaluation before surgery, another after six month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 2, 2018
Primary Completion (Actual)
December 21, 2018
Study Completion (Actual)
March 26, 2019
Study Registration Dates
First Submitted
December 3, 2017
First Submitted That Met QC Criteria
December 13, 2017
First Posted (Actual)
December 19, 2017
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 15, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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