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

NCT01945151 | Unknown

• 1 other identifier: 03559712.6.0000.0077
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

spastic hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Group 1 (G1) NMES is applied in the spastic antagonist muscle

EXPERIMENTAL

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).

Interventions

Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius). OTHER

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.

Group 1 (G1) NMES is applied in the spastic antagonist muscle

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Vale do Paraíba: lead

Study Sites (1)

Laboratório de Engenharia de Reabilitação Sensorio Motora

São José dos Campos, São Paulo, 55, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergio ST Takeshi, pesquisador

  Universidade do Vale do Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio ST Takeshi, pesquisadora

CONTACT

55 12 39947 1000; s.takeshi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: September 18, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

BR (1)