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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03377712
Other study ID # UFPE POSNEURO
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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