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

Brachial Plexus Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377712
• Other study ID #: UFPE POSNEURO
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: March 26, 2019

Study information

• Verified date: April 2019
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 26, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Injury
• Respiratory Evaluation
• Wounds and Injuries

Intervention

Device:
• optoelectronic plethysmography
Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations
• diaphragmatic ultrasound
Evaluates the diaphragmatic mobility through images, simple and non-invasive use
• Postural evaluation
Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive
• Pain evaluation
by means of questionnaires
• Evaluation of the function
through questionnaires
• Functional capacity assessment
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
through questionnaire

Locations

Country	Name	City	State
Brazil	Helen Fuzari	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thoracoabdominal kinematics	It will be evaluated through optoelectronic plethysmography	There will be two evaluations: one evaluation before surgery, another after six month
Primary	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	Postural evaluation	evaluates the patient's posture through photos, rapid examination, simple and non-invasive. Only the registration of images will be reactivated	There will be two evaluations: one evaluation before surgery, another after six month
Secondary	Pain	evaluation by means of questionnaire	There will be two evaluations: one evaluation before surgery, another after six month
Secondary	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).	There will be two evaluations: one evaluation before surgery, another after six month
Secondary	Functional capacity assessment	Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment	There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery
Secondary	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.	There will be two evaluations: one evaluation before surgery, another after six month