Stroke, AcuteNCT03840954
Effects of Neuromuscular Electrical Stimulation in Muscle Architecture and Functionality of Patients After Acute Stroke
A study testing Neuromuscular Electrical Stimulation in people with Stroke, Acute and Neuromuscular Electrical Stimulation, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Introduction: Stroke is a sudden illness, responsible for important neurological and cognitive sequelae that can result in functional limitations and dependence. It is the leading cause of neurological impairment in young adults and resting-related muscle loss is one of the major factors involved. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute, Neuromuscular Electrical Stimulation
- What is being tested?
- Neuromuscular Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Aug 2019to 30 Aug 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ischemic or hemorrhagic stroke performed by a neurologist based on clinical and neuroimaging characteristics;
- To present motor sequelae in the lower limb due to stroke.
Who cannot join
- Previous motor deficits
- Complete recovery of motor deficits before the initial evaluation;
- Conditions that prevent neuromuscular electrical stimulation such as skin lesions at the site of electrode placement, pacemaker and therapy intolerance.
- Time greater than 72 hours since hospitalization.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
HCPA
Porto Alegre, Rio Grande do Sul, 90035903
Graciele Sbruzzi, Doctor, +55(51)33597334, gsbruzzi@hcpa.edu.br
Débora Schmidt, +55(51)33597334, dschmidt@hcpa.edu.br
About this study
Introduction: Stroke is a sudden illness, responsible for important neurological and cognitive sequelae that can result in functional limitations and dependence. It is the leading cause of neurological impairment in young adults and resting-related muscle loss is one of the major factors involved. Early rehabilitation is essential for these patients and neuromuscular electrical stimulation (NMES) has been identified as an intervention alternative due to its known effects on the prevention of muscle loss in patients with various pathologies. Objective: To evaluate the effects of NMES associated with conventional physiotherapy compared to conventional physiotherapy on muscle thickness and functionality of patients with acute stroke. Methodology: This is a randomized clinical trial, which will be performed at the Emergency and Unit Unit of the Stroke of the Hospital de Clínicas of Porto Alegre (HCPA). Patients with acute stroke, with up to 72 hours of hospital admission, who present with lower limb force deficit due to the current stroke will be included. Patients will be randomized into two groups: intervention group, who will receive the application of NMES associated with conventional physiotherapy and control group, who will receive the conventional physiotherapy of the HCPA. NMES training will be applied once a day (30 minutes of application per session with an increase of five minutes each week and gradual reduction in OFF time), five days a week until hospital discharge or up to a maximum of three weeks. The following outcomes will be assessed before and after the intervention: quadriceps and tibial thickness and quality of the quadriceps and tibialis anterior, muscle strength, stroke severity, gait, functionality and disability.
Read the detailed description
Stroke is the leading cause of neurological impairment in young adults, and early rehabilitation is essential for the recovery of these patients.
It is already known that muscle loss is one of the main factors responsible for functional disability and dependence in stroke survivors, being observed already in the acute phase and mainly in the lower limbs. The physiological mechanisms involved in stroke-related muscle loss, such as muscle inactivity, denervation, malnutrition, inflammation and metabolic disorders, among others have been reported in studies, but there is no consistent evidence regarding effective therapies to avoid muscle loss.
The NMES is already widely used for the prevention of muscular loss in patients with various pathologies. Studies have also reported the efficacy of NMES in patients with subacute or chronic stroke. In patients with acute stroke, the literature is rather scarce. The investigators are aware of only one study that evaluated the effects of NMES on muscle mass loss, but the authors did not evaluate the effects of this intervention on the physical performance or functionality of the patients. Thus, the investigators consider the importance of further studies to know the effects of NMES on muscle loss in patients with acute stroke and the need to evaluate the effects of NMES on the physical performance functionality of these patients aiming at the possibility of offering an intervention option precocious and effective for this population.
The objective of this study is to evaluate the effects of NMES associated with conventional physiotherapy compared to conventional physiotherapy in the muscular architecture and functionality of patients with acute stroke.
This is a randomized clinical trial in which the participants will be randomly divided into experimental group (EG) and control group (CG), being evaluated before and after the intervention.
The sample will be composed of hospitalized patients diagnosed with acute stroke at the Hospital de Clínicas de Porto Alegre (HCPA).
The estimated sample is 70 patients (35 in each group). Waiting for a 0.5 cm difference in muscle thickness between groups and a standard deviation of 0.68 and 2 of 0.80, with a significance level of 5%, 80% power.
Randomization will be performed through data generated by a computer program that presents the coded distribution. The sequence generation of the numbers to be randomized will be performed by a researcher blind to the study - after selection of the patients according to the eligibility criteria - keeping it confidential until the beginning of the intervention.
Data collect:
Socio-demographic data will be collected such as: age and sex; anthropometric variables: weight, height and BMI; and clinical data: stroke region, side of hemiparesis, comorbidities, complications during the hospitalization period (eg pneumonia, need for decompressive craniectomy), functional condition prior to the current stroke, time to start physical therapy, time to onset of NMES, total time of NMES, time to reach orthostasis and time to start ambulation. These data will be obtained through the review of medical records and interviews with patients or relatives.
Assessments: The evaluations described below will be performed within 72 hours of hospital admission and repeated at hospital discharge or within 21 days.
Assessment of muscle architecture - The assessment of muscle thickness will be performed in the femoral and tibial quadriceps muscles (TA). The images will be obtained by ultrasound using the Portable Ultrasound System (Vivid i®, GE) with a linear arrangement probe (60mm, 7.5 MHz - Vivid i®, GE). The same researcher (who will be blinded for the interventions) will do all the evaluations, which will be performed with the musculature at rest.
Muscle Strength Assessment: Manual Dynamometry, Medical Research Council (MRC)
Functional and Inability Assessment: Barthel's Index Modified
Walking assessment and functional capacity: Functional Ambulation Category (FAC)
- Being tested
- Neuromuscular Electrical Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationOther
The application of NMES will be performed with the patient positioned in the supine position in the bed. Self-adhesive electrodes will be positioned at the motor points of the quadriceps and anterior tibial muscles respectively. A symmetrical biphasic pulsed current with a frequency of 80 Hz, a pulse width of 500 μs and an intensity at the motor threshold will be applied up to the maximum tolerated by the patient. ON and OFF time and total session time will be used according to protocol with progressive increase of the total intervention time and reduction of OFF time of the NMES. The device used will be the Neurodyn II model, manufactured by IBRAMED.
Patients will receive NMES for as long as they remain hospitalized or for up to 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Electrical Stimulation | Experimental | The experimental group will receive the application of NMES associated with conventional physiotherapy. After the NMES application, conventional physiotherapy will be performed. The exercises performed will be according to the patient's physical condition, and the conducts will always be performed seeking the maximum possible functional performance for the patient. The conducts adopted according to the standard routine of the HCPA stroke unit are: passive, active, assisted and / or active exercises; muscle stretching; selective hip extension; trunk stabilization training in sedestation; orthostasis training and walking training. Receives: Other: Neuromuscular Electrical Stimulation |
| Group Control | No intervention | The control group will only receive conventional physiotherapy, composed of the same exercises performed in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle thickness
Evaluated by muscular echography (cm)
Measured: three weeks
Thickness of the anterior tibial muscle
Evaluated by muscular echography (cm)
Measured: three weeks
Secondary outcomes (8)
Functionality - Barthel Index for Activities of Daily Living
The score ranges from 0 to 100 points (90 to 100 - independent, 60 to 89 - slightly dependent, 40 to 59 - moderately dependent, 20 to 39 - severely dependent and less than 20 - totally dependent).
Measured: three weeks
Muscle strength - Medical Research Council (MRC) Scale
The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors and abductors of the shoulder) and lower extremities (dorsal ankle flexors, knee extensors, and hip flexors). For each muscle group will be assigned a score between 0 (complete paralysis) and 5 (normal force), and the total score can vary between 0 up to 60 points.
Measured: three weeks
Functional walking - Functional Ambulation Categories
Evaluates the degree of assistance required for ambulation. It distinguishes six categories for ambulation ability (1 to 3 - need for physical assistance during walking, 4 - requires only supervision and 5 and 6 - independent walking).
Measured: three weeks
Dynamometry - Knee extension
Dynamometry (kg)
Measured: three weeks
Dynamometry - ankle dorsiflexion
Dynamometry (kg)
Measured: three weeks
Sit and stand up to 30 seconds
Assess the maximum number of times it is possible to get up and sit down in 30 seconds
Measured: three weeks
Modified Rankin Scale
Evaluates the degree of disability and dependence in daily life with a score of 0: without any symptom at 6: death
Measured: three weeks
10-meter walking test
Evaluates gait speed and cadence
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start30 Aug 2019 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graciele Sbruzzi, doctor, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840954
- Sponsor's protocol ID
- 20180460
- Status last verified
- Jun 2019
- First submitted
- 12 Feb 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation in Muscle Architecture and Functionality of Patients After Acute Stroke
- ClinicalTrials.gov ID
- NCT03840954
- Acronym / sponsor ID
- 20180460
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 30 Aug 2019 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 15 Feb 2019 (actual)
- 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.
Introduction: Stroke is a sudden illness, responsible for important neurological and cognitive sequelae that can result in functional limitations and dependence. It is the leading cause of neurological impairment in young adults and resting-related muscle loss is one of the major factors involved. Early rehabilitation is essential for these patients and neuromuscular electrical stimulation (NMES) has been identified as an intervention alternative due to its known effects on the prevention of muscle loss in patients with various pathologies. Objective: To evaluate the effects of NMES associated with conventional physiotherapy compared to conventional physiotherapy on muscle thickness and functionality of patients with acute stroke. Methodology: This is a randomized clinical trial, which will be performed at the Emergency and Unit Unit of the Stroke of the Hospital de Clínicas of Porto Alegre (HCPA). Patients with acute stroke, with up to 72 hours of hospital admission, who present with lower limb force deficit due to the current stroke will be included. Patients will be randomized into two groups: intervention group, who will receive the application of NMES associated with conventional physiotherapy and control group, who will receive the conventional physiotherapy of the HCPA. NMES training will be applied once a day (30 minutes of application per session with an increase of five minutes each week and gradual reduction in OFF time), five days a week until hospital discharge or up to a maximum of three weeks. The following outcomes will be assessed before and after the intervention: quadriceps and tibial thickness and quality of the quadriceps and tibialis anterior, muscle strength, stroke severity, gait, functionality and disability.
Detailed description
Stroke is the leading cause of neurological impairment in young adults, and early rehabilitation is essential for the recovery of these patients.
It is already known that muscle loss is one of the main factors responsible for functional disability and dependence in stroke survivors, being observed already in the acute phase and mainly in the lower limbs. The physiological mechanisms involved in stroke-related muscle loss, such as muscle inactivity, denervation, malnutrition, inflammation and metabolic disorders, among others have been reported in studies, but there is no consistent evidence regarding effective therapies to avoid muscle loss.
The NMES is already widely used for the prevention of muscular loss in patients with various pathologies. Studies have also reported the efficacy of NMES in patients with subacute or chronic stroke. In patients with acute stroke, the literature is rather scarce. The investigators are aware of only one study that evaluated the effects of NMES on muscle mass loss, but the authors did not evaluate the effects of this intervention on the physical performance or functionality of the patients. Thus, the investigators consider the importance of further studies to know the effects of NMES on muscle loss in patients with acute stroke and the need to evaluate the effects of NMES on the physical performance functionality of these patients aiming at the possibility of offering an intervention option precocious and effective for this population.
The objective of this study is to evaluate the effects of NMES associated with conventional physiotherapy compared to conventional physiotherapy in the muscular architecture and functionality of patients with acute stroke.
This is a randomized clinical trial in which the participants will be randomly divided into experimental group (EG) and control group (CG), being evaluated before and after the intervention.
The sample will be composed of hospitalized patients diagnosed with acute stroke at the Hospital de Clínicas de Porto Alegre (HCPA).
The estimated sample is 70 patients (35 in each group). Waiting for a 0.5 cm difference in muscle thickness between groups and a standard deviation of 0.68 and 2 of 0.80, with a significance level of 5%, 80% power.
Randomization will be performed through data generated by a computer program that presents the coded distribution. The sequence generation of the numbers to be randomized will be performed by a researcher blind to the study - after selection of the patients according to the eligibility criteria - keeping it confidential until the beginning of the intervention.
Data collect:
Socio-demographic data will be collected such as: age and sex; anthropometric variables: weight, height and BMI; and clinical data: stroke region, side of hemiparesis, comorbidities, complications during the hospitalization period (eg pneumonia, need for decompressive craniectomy), functional condition prior to the current stroke, time to start physical therapy, time to onset of NMES, total time of NMES, time to reach orthostasis and time to start ambulation. These data will be obtained through the review of medical records and interviews with patients or relatives.
Assessments: The evaluations described below will be performed within 72 hours of hospital admission and repeated at hospital discharge or within 21 days.
Assessment of muscle architecture - The assessment of muscle thickness will be performed in the femoral and tibial quadriceps muscles (TA). The images will be obtained by ultrasound using the Portable Ultrasound System (Vivid i®, GE) with a linear arrangement probe (60mm, 7.5 MHz - Vivid i®, GE). The same researcher (who will be blinded for the interventions) will do all the evaluations, which will be performed with the musculature at rest.
Muscle Strength Assessment: Manual Dynamometry, Medical Research Council (MRC)
Functional and Inability Assessment: Barthel's Index Modified
Walking assessment and functional capacity: Functional Ambulation Category (FAC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Electrical Stimulation | Experimental | Other: Neuromuscular Electrical StimulationThe experimental group will receive the application of NMES associated with conventional physiotherapy. After the NMES application, conventional physiotherapy will be performed. The exercises performed will be according to the patient's physical condition, and the conducts will always be performed seeking the maximum possible functional performance for the patient. The conducts adopted according to the standard routine of the HCPA stroke unit are: passive, active, assisted and / or active exercises; muscle stretching; selective hip extension; trunk stabilization training in sedestation; orthostasis training and walking training. |
| Group Control | No intervention | –The control group will only receive conventional physiotherapy, composed of the same exercises performed in the experimental group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of ischemic or hemorrhagic stroke performed by a neurologist based on clinical and neuroimaging characteristics;
- To present motor sequelae in the lower limb due to stroke.
Key exclusion criteria (4 listed)
- Previous motor deficits
- Complete recovery of motor deficits before the initial evaluation;
- Conditions that prevent neuromuscular electrical stimulation such as skin lesions at the site of electrode placement, pacemaker and therapy intolerance.
- Time greater than 72 hours since hospitalization.
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 |
|---|---|---|
| Neuromuscular Electrical StimulationThe application of NMES will be performed with the patient positioned in the supine position in the bed. Self-adhesive electrodes will be positioned at the motor points of the quadriceps and anterior tibial muscles respectively. A symmetrical biphasic pulsed current with a frequency of 80 Hz, a pulse width of 500 μs and an intensity at the motor threshold will be applied up to the maximum tolerated by the patient. ON and OFF time and total session time will be used according to protocol with progressive increase of the total intervention time and reduction of OFF time of the NMES. The device used will be the Neurodyn II model, manufactured by IBRAMED. Patients will receive NMES for as long as they remain hospitalized or for up to 3 weeks. | Other | Neuromuscular Electrical Stimulation |
Primary outcome
Quadriceps muscle thickness
Time frame: three weeks
Evaluated by muscular echography (cm)
Thickness of the anterior tibial muscle
Time frame: three weeks
Evaluated by muscular echography (cm)
8 secondary outcomes
Functionality - Barthel Index for Activities of Daily Living
Time frame: three weeks
Muscle strength - Medical Research Council (MRC) Scale
Time frame: three weeks
Functional walking - Functional Ambulation Categories
Time frame: three weeks
Dynamometry - Knee extension
Time frame: three weeks
Dynamometry - ankle dorsiflexion
Time frame: three weeks
Sit and stand up to 30 seconds
Time frame: three weeks
Modified Rankin Scale
Time frame: three weeks
10-meter walking test
Time frame: three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Graciele Sbruzzi, doctor study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation in people with Stroke, Acute and Neuromuscular Electrical Stimulation, run by Hospital de Clinicas de Porto Alegre 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 2 inclusion and 4 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 1 Jul 2019. 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 Graciele Sbruzzi, doctor (+55(51)33577334, gsbruzzi@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps muscle thickness (time frame: three weeks). The study lists 2 primary outcomes in all. 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 1 Jul 2019.