Brachial Plexus InjuryNCT03377712
Surgical Repercussions in Respiratory System in Patients With Post-Traumatic Brachial Plexus Injuries: A Prospective Cohort Study
An observational study of Brachial Plexus Injury and Respiratory Evaluation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Injury, Respiratory Evaluation
- What is being tested?
- optoelectronic plethysmography, diaphragmatic ultrasound and Postural evaluation
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2018to 26 Mar 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
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
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Brachial Plexus Injury, Respiratory Evaluation
- Being tested
- optoelectronic plethysmography, diaphragmatic ultrasound, Postural evaluation, Pain evaluation, Evaluation of the function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optoelectronic plethysmographyDevice
Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations
diaphragmatic ultrasoundDevice
Evaluates the diaphragmatic mobility through images, simple and non-invasive use
Postural evaluationDevice
Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive
Pain evaluationDevice
by means of questionnaires
Evaluation of the functionDevice
through questionnaires
Functional capacity assessmentDevice
Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
Quality of life assessmentDevice
through questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 | |
| 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. Receives: Device: optoelectronic plethysmography; Device: diaphragmatic ultrasound; Device: Postural evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
thoracoabdominal kinematics
It will be evaluated through optoelectronic plethysmography
Measured: There will be two evaluations: one evaluation before surgery, another after six month
mobility diaphragmatic
It will be evaluated by means of an ultrasound
Measured: There will be two evaluations: one evaluation before surgery, another after six month
Secondary outcomes (5)
Postural evaluation
evaluates the patient's posture through photos, rapid examination, simple and non-invasive. Only the registration of images will be reactivated
Measured: There will be two evaluations: one evaluation before surgery, another after six month
Pain
evaluation by means of questionnaire
Measured: There will be two evaluations: one evaluation before surgery, another after six month
Evaluation of the function
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).
Measured: There will be two evaluations: one evaluation before surgery, another after six month
Functional capacity assessment
Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
Measured: There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery
Quality of life assessment
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.
Measured: There will be two evaluations: one evaluation before surgery, another after six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start2 Jan 2018
- Primary completion21 Dec 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Fisio, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377712
- Sponsor's protocol ID
- UFPE POSNEURO
- Status last verified
- Apr 2019
- First submitted
- 3 Dec 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03377712
- Acronym / sponsor ID
- UFPE POSNEURO
- Conditions
- Brachial Plexus Injury, Respiratory Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachial Plexus Injury group | – | 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 assessmentPatients 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 |
| Paired group | – | Device: optoelectronic plethysmography, Device: diaphragmatic ultrasound, Device: Postural evaluationHealthy 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optoelectronic plethysmographyEvaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations | Device | Brachial Plexus Injury group, Paired group |
| diaphragmatic ultrasoundEvaluates the diaphragmatic mobility through images, simple and non-invasive use | Device | Brachial Plexus Injury group, Paired group |
| Postural evaluationEvaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive | Device | Brachial Plexus Injury group, Paired group |
| Pain evaluationby means of questionnaires | Device | Brachial Plexus Injury group |
| Evaluation of the functionthrough questionnaires | Device | Brachial Plexus Injury group |
| Functional capacity assessmentEvaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment | Device | Brachial Plexus Injury group |
| Quality of life assessmentthrough questionnaire | Device | Brachial Plexus Injury group |
Primary outcome
thoracoabdominal kinematics
Time frame: There will be two evaluations: one evaluation before surgery, another after six month
It will be evaluated through optoelectronic plethysmography
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
5 secondary outcomes
Postural evaluation
Time frame: 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 of the function
Time frame: 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
Quality of life assessment
Time frame: There will be two evaluations: one evaluation before surgery, another after six month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Related trials for Brachial Plexus Injury
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Not yet recruiting
Constraint Therapy for Brachial Plexus Birth Injury
Brachial Plexus Birth Palsy
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries
Obstetric Brachial Plexus Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Injury and Respiratory Evaluation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thoracoabdominal kinematics (time frame: There will be two evaluations: one evaluation before surgery, another after six month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.