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

NCT ID: NCT03377712

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2019-03-26

Brief Summary

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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

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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

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Brachial Plexus Injury Respiratory Evaluation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

optoelectronic plethysmography

Intervention Type DEVICE

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

diaphragmatic ultrasound

Intervention Type DEVICE

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

Postural evaluation

Intervention Type DEVICE

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

Pain evaluation

Intervention Type DEVICE

by means of questionnaires

Evaluation of the function

Intervention Type DEVICE

through questionnaires

Functional capacity assessment

Intervention Type DEVICE

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

Quality of life assessment

Intervention Type DEVICE

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.

optoelectronic plethysmography

Intervention Type DEVICE

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

diaphragmatic ultrasound

Intervention Type DEVICE

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

Postural evaluation

Intervention Type DEVICE

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

Interventions

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optoelectronic plethysmography

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

Intervention Type DEVICE

diaphragmatic ultrasound

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

Intervention Type DEVICE

Postural evaluation

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

Intervention Type DEVICE

Pain evaluation

by means of questionnaires

Intervention Type DEVICE

Evaluation of the function

through questionnaires

Intervention Type 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

Intervention Type DEVICE

Quality of life assessment

through questionnaire

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Helen Fisio

Doctor student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helen Fuzari

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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UFPE POSNEURO

Identifier Type: -

Identifier Source: org_study_id

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