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

Cerebrovascular Accident Clinical Trial

— EENM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01945151
• Other study ID #: 03559712.6.0000.0077
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2013
• Last updated: September 13, 2013
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: Universidade do Vale do Paraíba
• Contact: Sergio ST Takeshi, pesquisadora
• Phone: 55 12 39947 1000
• Email: s.takeshi[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Brazil	Laboratório de Engenharia de Reabilitação Sensorio Motora	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	Yes