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Status unknownNCT01945151EENMUpdated Sep 18, 2013

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

An interventional study of Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius). in Cerebrovascular Accident, sponsored by Universidade do Vale do Paraíba. Status unknown at 1 site in Brazil. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-09-18.

Sponsored by Universidade do Vale do Paraíba · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Cerebrovascular Accident

Keywords

  • spastic hemiparesis
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 15 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

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Lead sponsor

Universidade do Vale do Paraíba is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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).

Interventions

  • OtherGroup 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.

06

What researchers measure

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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Laboratório de Engenharia de Reabilitação Sensorio Motora
    São José dos Campos, São Paulo 55, Brazil
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Sep 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2013
First posted
Sep 18, 2013
Start
Jun 2013
Primary completionEst.
Sep 2013
CompletionEst.
Nov 2013
Last update
Sep 18, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01945151
Lead sponsor
Universidade do Vale do Paraíba
Responsible party
Sponsor
First posted
Sep 18, 2013
Start date
Jun 2013
Primary completion
Sep 2013 (estimated)
Completion
Nov 2013 (estimated)
Last update
Sep 18, 2013

Study contacts

Sergio ST Takeshi, pesquisadora
Contact
s.takeshi@hotmail.com
55 12 39947 1000 ext. 2066
Sergio ST Takeshi, pesquisador
principal investigator · Universidade do Vale do Paraíba

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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