- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02255708
Effects of an Intervention Program by Proprioceptive Neuromuscular Facilitation, in Muscle Force Irradiation.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
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:
- João Eduardo Araujo, lecturer
- Phone Number: +55-16-6024416
- Email: araujoje@fmrp.usp.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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