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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03377712
Enrollment
20
Registered
2017-12-19
Start date
2018-01-02
Completion date
2019-03-26
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Injury, Respiratory Evaluation

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.

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.

Interventions

DEVICEoptoelectronic plethysmography

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

DEVICEPostural evaluation

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

by means of questionnaires

DEVICEEvaluation of the function

through questionnaires

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

DEVICEQuality of life assessment

through questionnaire

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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 \-

Design outcomes

Primary

MeasureTime frameDescription
thoracoabdominal kinematicsThere will be two evaluations: one evaluation before surgery, another after six monthIt will be evaluated through optoelectronic plethysmography
mobility diaphragmaticThere will be two evaluations: one evaluation before surgery, another after six monthIt will be evaluated by means of an ultrasound

Secondary

MeasureTime frameDescription
Evaluation of the functionThere will be two evaluations: one evaluation before surgery, another after six monththrough 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).
Postural evaluationThere will be two evaluations: one evaluation before surgery, another after six monthevaluates the patient's posture through photos, rapid examination, simple and non-invasive. Only the registration of images will be reactivated
Quality of life assessmentThere will be two evaluations: one evaluation before surgery, another after six monththrough 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.
Functional capacity assessmentThere will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgeryEvaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
PainThere will be two evaluations: one evaluation before surgery, another after six monthevaluation by means of questionnaire

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026