Cerebrovascular AccidentEENMNCT01945151
Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.
A study testing Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius). in people with Cerebrovascular Accident, run by Universidade do Vale do Paraíba at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Engenharia de Reabilitação Sensorio Motora
São José dos Campos, São Paulo, 55
Sergio ST Takeshi, pesquisadora, 55 12 8137-1012 ext. 2066, s.takeshi@hotmail.com
About this study
Official title: Analysis of the Electrical Muscle Activity and Resistance to Movement After Pplication Neuromuscular Electrical Stimulation (EENM) in Patients With Hemiparesis Spastic.
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.
- Conditions
- Cerebrovascular Accident
- Being tested
- Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).
- Keywords
- spastic hemiparesis
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio ST Takeshi, pesquisador, Principal investigator, Universidade do Vale do Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945151
- Sponsor's protocol ID
- 03559712.6.0000.0077
- Acronym
- EENM
- Status last verified
- Sep 2013
- First submitted
- 27 Jun 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Electrical Muscle Activity and Resistance to Movement After Pplication Neuromuscular Electrical Stimulation (EENM) in Patients With Hemiparesis Spastic.
- ClinicalTrials.gov ID
- NCT01945151
- Acronym / sponsor ID
- EENM / 03559712.6.0000.0077
- Conditions
- Cerebrovascular Accident
- Keywords
- spastic hemiparesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 (G1) NMES is applied in the spastic antagonist muscle | Experimental | Other: Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).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). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group 1 (G1) NMES is applied in the spastic antagonist muscle |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio ST Takeshi, pesquisador principal investigator
Universidade do Vale do Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius). in people with Cerebrovascular Accident, run by Universidade do Vale do Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio ST Takeshi, pesquisadora (55 12 39947 1000 ext. 2066, s.takeshi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.