NCT03377712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

December 3, 2017

Last Update Submit

April 15, 2019

Conditions

Brachial Plexus InjuryRespiratory Evaluation

Outcome Measures

Primary Outcomes (2)

  • thoracoabdominal kinematics

    It will be evaluated through optoelectronic plethysmography

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

  • mobility diaphragmatic

    It will be evaluated by means of an ultrasound

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

Secondary Outcomes (5)

  • Postural evaluation

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

  • Pain

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

  • Evaluation of the function

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

  • Functional capacity 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

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

Study Arms (2)

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 plethysmographyDevice: diaphragmatic ultrasoundDevice: Postural evaluationDevice: Pain evaluationDevice: Evaluation of the functionDevice: Functional capacity assessmentDevice: 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.

Device: optoelectronic plethysmographyDevice: diaphragmatic ultrasoundDevice: Postural evaluation

Interventions

optoelectronic plethysmographyDEVICE

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

Brachial Plexus Injury groupPaired group
diaphragmatic ultrasoundDEVICE

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

Brachial Plexus Injury groupPaired group
Postural evaluationDEVICE

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

Brachial Plexus Injury groupPaired group
Pain evaluationDEVICE

by means of questionnaires

Brachial Plexus Injury group
Evaluation of the functionDEVICE

through questionnaires

Brachial Plexus Injury group
Functional capacity assessmentDEVICE

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

Brachial Plexus Injury group
Quality of life assessmentDEVICE

through questionnaire

Brachial Plexus Injury group

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Fuzari

Recife, Pernambuco, 51021-360, Brazil

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor student

Study Record Dates

First Submitted

December 3, 2017

First Posted

December 19, 2017

Study Start

January 2, 2018

Primary Completion

December 21, 2018

Study Completion

March 26, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

BR(1)