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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02255708
Other study ID # U1111-1161-5560
Secondary ID
Status Recruiting
Phase Phase 1
First received September 23, 2014
Last updated September 29, 2014
Start date July 2014

Study information

Verified date September 2014
Source University of Sao Paulo
Contact Ana Cláudia S Ferreira, graduate student
Phone +55-16 988027661
Email acsilvaf35@gmail.com
Is FDA regulated No
Health authority Brasil: Faculdade de Medicina de Ribeirão Preto - USP
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Assessment of Muscle Force Irradiation

Intervention

Other:
Proprioceptive Neuromuscular Facilitation - PNF


Locations

Country Name City State
Brazil Laboratory of Neuropsychobiology and Motor Behavior, Ribeirão Preto São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of muscle force irradiation, through surface electromyography. 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. No