Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients. (EENM)
Primary Purpose
Cerebrovascular Accident
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring spastic hemiparesis
Eligibility 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.
Sites / Locations
- Laboratório de Engenharia de Reabilitação Sensorio MotoraRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group 1 (G1) NMES is applied in the spastic antagonist muscle
Arm Description
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).
Outcomes
Primary Outcome Measures
Analysis of the electrical muscle activity and resistance to movement after application of neuromuscular electrical stimulation (NMES) in patients with spastic hemiparesis.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01945151
First Posted
June 27, 2013
Last Updated
September 13, 2013
Sponsor
Universidade do Vale do Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT01945151
Brief Title
Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.
Acronym
EENM
Official Title
Analysis of the Electrical Muscle Activity and Resistance to Movement After Pplication Neuromuscular Electrical Stimulation (EENM) in Patients With Hemiparesis Spastic.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Vale do Paraíba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
spastic hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (G1) NMES is applied in the spastic antagonist muscle
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).
Intervention Description
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 Measure Information:
Title
Analysis of the electrical muscle activity and resistance to movement after application of neuromuscular electrical stimulation (NMES) in patients with spastic hemiparesis.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio ST Takeshi, pesquisadora
Phone
55 12 39947 1000
Ext
2066
Email
s.takeshi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio ST Takeshi, pesquisador
Organizational Affiliation
Universidade do Vale do Paraíba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratório de Engenharia de Reabilitação Sensorio Motora
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
55
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio ST Takeshi, pesquisadora
Phone
55 12 8137-1012
Ext
2066
Email
s.takeshi@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.
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