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

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ClinicalTrials.gov Identifier: NCT01945151
Recruitment Status : Unknown
Verified September 2013 by Universidade do Vale do Paraíba.
Recruitment status was:  Recruiting
First Posted : September 18, 2013
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):
Universidade do Vale do Paraíba

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Other: Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius). Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of the Electrical Muscle Activity and Resistance to Movement After Pplication Neuromuscular Electrical Stimulation (EENM) in Patients With Hemiparesis Spastic.
Study Start Date : June 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : November 2013

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945151


Contacts
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Contact: Sergio ST Takeshi, pesquisadora 55 12 39947 1000 ext 2066 s.takeshi@hotmail.com

Locations
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Brazil
Laboratório de Engenharia de Reabilitação Sensorio Motora Recruiting
São José dos Campos, São Paulo, Brazil, 55
Contact: Sergio ST Takeshi, pesquisadora    55 12 8137-1012 ext 2066    s.takeshi@hotmail.com   
Sponsors and Collaborators
Universidade do Vale do Paraíba
Investigators
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Principal Investigator: Sergio ST Takeshi, pesquisador Universidade do Vale do Paraíba

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Responsible Party: Universidade do Vale do Paraíba
ClinicalTrials.gov Identifier: NCT01945151     History of Changes
Other Study ID Numbers: 03559712.6.0000.0077
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Universidade do Vale do Paraíba:
spastic hemiparesis

Additional relevant MeSH terms:
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Stroke
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms