Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients. (EENM)

September 13, 2013 updated by: Universidade do Vale do Paraíba

Analysis of the Electrical Muscle Activity and Resistance to Movement After Pplication Neuromuscular Electrical Stimulation (EENM) in Patients With Hemiparesis Spastic.

To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.

The specific objectives are:

  • Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in spastic muscle (gastrocnemius).
  • Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in the spastic antagonist muscle (tibialis anterior).
  • Compare the risk of falls after application of Neuromuscular Electrical Stimulation in both muscles studied.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Most hemiparetic patients can develop spasticity, characterized by neuronal hyperexcitability, increased resistance to passive stretch, Babinski sign, clonus, reflexes and involuntary spasms skin.

As a consequence, there may be contractures and muscle shortening, generating functional limitations. Neuromuscular Electrical Stimulation feature that can control the spasticity through reciprocal inhibition, muscle relaxation and sensory stimulation. The goal will be to evaluate and compare the effects of neuromuscular electrical stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

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

Study Locations

  • Brazil
    • São Paulo
      • São José dos Campos, São Paulo, Brazil, 55
        • Recruiting
        • Laboratório de Engenharia de Reabilitação Sensorio Motora
        • 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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • involve patients who have spasticity grade 1, 1 + and 2 of the gastrocnemius muscle, which ambulate with or without assistance devices, patients who tolerate the stimulus and have preserved cognition.

Exclusion Criteria:

  • involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (G1) NMES is applied in the spastic antagonist muscle
The parameters considered for the application of NMES are: frequency of 50Hz, the wavelength of 350m / s, 10 seconds of contraction of 20 seconds of rest to total 15 minutes. During the application of NMES patients will be positioned supine on the bed with knees flexed semi supported on roller positioning. The G1 apply NMES on the motor point of the tibialis anterior and triceps surae lengthening held along with the contraction (reciprocal inhibition).
Other: Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).
The G2 apply NMES in the gastrocnemius motor point and the rest will be done during stretching of the gastrocnemius muscle (autogenic inhibition). Five consecutive sessions will be held in the morning and afternoon in the laboratory of Sensory Motor Rehabilitation Engineering.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the electrical muscle activity and resistance to movement after application of neuromuscular electrical stimulation (NMES) in patients with spastic hemiparesis.
Time Frame: 12 months
The G1 apply Neuromuscular Electrical Stimulation on the motor point of the tibialis anterior and triceps surae lengthening held along with the contraction (reciprocal inhibition). The G2 apply electrical muscle activity and resistance to movement after application of neuromuscular electrical stimulation (NMES) in patients with spastic hemiparesis.
12 months

Collaborators and Investigators

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

Sponsor

Universidade do Vale do Paraíba

Investigators

  • Principal Investigator: Sergio ST Takeshi, pesquisador, Universidade do Vale do Paraíba

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

June 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 13, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03559712.6.0000.0077

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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