Effects of an Intervention Program by Proprioceptive Neuromuscular Facilitation, in Muscle Force Irradiation.

September 29, 2014 updated by: Ana Cláudia Silva Ferreira, University of Sao Paulo

Electromyography Evaluation of the Stabilizing Muscles of the Scapula and Tibial Anterior Muscle, After an Intervention Program by Proprioceptive Neuromuscular Facilitation in Muscle Force Irradiation.

The present study aims to assess through surface electromyography, the effectiveness of proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing muscles of the scapula and the anterior tibial muscle.

Study Overview

Detailed Description

Healthy subjects and subjects with demyelinating polyneuropathy are involved in the study.

Healthy patients are arranged in two groups of stimulation: FNP Group (intervention proprioceptive neuromuscular facilitation) - CC Group (intervention classic cinesioterapia). The electromyographic response of the stabilizing muscles of the scapula of each individual will be assessed prior to application of the protocols, during the execution of the protocols and immediately after stopping in a single session.

Patients with demyelinating polyneuropathy are arranged in a single treatment group and will be treated at a frequency of twice a week for five weeks. In each session, the PNF patterns will be repeated four times, on both sides, stimulating muscle irradiation and evoking the contraction of the tibialis anterior muscle. During the repetition of the patterns, the dorsiflexor muscle response of each patient will be obtained by an electromyography (EMG) surface.

The data of the RMS values obtained in the first session will be normalized and transformed into percentage. The average RMS of each diagonal at the beginning of treatment corresponds to 100% of TA muscle activation. The RMS values obtained in the last session will be normalized as a percentage, taking into account the results of the first evaluation. After normalization, data from the first and last sessions will besubjected to the for paired t-test.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ana Cláudia S Ferreira, graduate student
  • Phone Number: 0740 +55-16 988027661
  • Email: acsilvaf35@gmail.com

Study Contact Backup

  • Name: João Eduardo Araujo, lecturer
  • Phone Number: 0740 +55-16-6024416
  • Email: araujoje@fmrp.usp.br

Study Locations

    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil
        • Recruiting
        • Laboratory of Neuropsychobiology and Motor Behavior,
        • Contact:
          • Ana Cláudia s Ferreira, graduate student
          • Phone Number: +55-16-988027661
          • Email: acsilvaf35@gmail.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy individuals group: who agree to participate in the study with no history of previous trauma or disease of the shoulder girdle, with absence of clinical signs painful in the shoulder joint.

Group with demyelinating polyneuropathy: both sexes, carriers of CMT-1A disease with functional changes in the lower limbs with good cognition and difficulty of to ambulate with and without assistance.

Exclusion Criteria:

Healthy individuals group: subject with restricted range of motion, muscle weakness, cognitive impairment, which exhibits a pathology that leads to alterations in muscle recruitment.

Patients with polyneuropathy: cardiac arrhythmias, uncontrolled hypertension, severe cardiovascular disease and respiratory problems. The use of own medicines to treat pathology was accepted.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy group.
Group formed by healthy patients.
Other: Group with demyelinating polyneuropathy
Group formed by patients with demyelinating polyneuropathy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of muscle force irradiation, through surface electromyography.
Time Frame: This evaluation of patients is performed in only one day, being made before, during and after the application of the protocols. It is estimated that the results are collected in one years.
Irradiation of muscle strength will be assessed using surface electromyography, which shows the activation or not of the muscles evaluated.
This evaluation of patients is performed in only one day, being made before, during and after the application of the protocols. It is estimated that the results are collected in one years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • U1111-1161-5560

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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