StrokeNCT03913624
Effectiveness of Neuromuscular Electrical Stimulation After Stroke
A study testing Neuromuscular electrical stimulation in people with Stroke, run by University of Valencia at 1 site in Spain.
Trial summary
A Randomized Clinical Trial (RCT) was conducted to determine the effects of two neuromuscular electrical stimulation protocols with different stimulation frequencies on motor recovery in older adults with spastic hemiparesis after a stroke. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2009to Sep 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Post-stroke spastic hemiparesis
- Mild-moderate hand impairment
- A score ≤ 3 on the modified Ashworth scale for wrist and finger flexors
- Active wrist extension ≥ 5º from the resting position
- Wrist extension response to stimulation
Show all 9Show fewer
- Post-stroke period < 18 months
- Clinical stability
- Mini-Mental State Examination score ≥ 23
Who cannot join
- Previous hemiparesis due to stroke
- Dermatological reactions with the application of stimulation
- Significant sensory deficits in the affected arm
- Previous musculoskeletal problems of the hand
- Treatment with the botulin toxin
- Anti-spastic medication usage
Show all 14Show fewer
- Cardiac pacemaker, implanted electronic device, or metal implants in the affected arm
- Complex regional pain syndrome
- Severe aphasia, history of epileptic seizures, psychiatric disorder or important alterations of behavior
- Severe visual impairment
- Any comorbid neurological disease
- Important deformity or obesity that affects the application of the NMES
- Potentially fatal cardiac arrhythmia or another decompensated heart disease
- Systemic infectious process, cancer or another terminal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 35 Hz Versus 50 Hz Frequency Stimulation Effects on Motor Recovery in Older Adults After Stroke. A Randomized Clinical Trial
A Randomized Clinical Trial (RCT) was conducted to determine the effects of two neuromuscular electrical stimulation protocols with different stimulation frequencies on motor recovery in older adults with spastic hemiparesis after a stroke.
Read the detailed description
Impairment of the upper limb is one of the most frequent consequences of stroke and directly impacts on the patient's functional status and quality of life. It is estimated that less than 50% of stroke survivors will recover arm function, which will exert a great economic, social and personal toll.
Neuromuscular electrical stimulation (NMES) is one of the techniques suggested for upper limb recovery in stroke patients. However, after considering the bibliographic background, more studies are required in order to test its effectiveness, to establish the most efficient NMES protocols and to assess the characteristics of the patients who can benefit the most from this treatment. With this regard, the parameters of the stimulation are currently subject to debate, and more data are needed to optimize the application of this treatment. The aim of this study was to evaluate and compare the effects of two neuromuscular electrical stimulation protocols with different stimulation frequencies on motor impairment, kinaesthetic sensation, functional motor ability, activities of daily living, and quality of life in older adults with spastic hemiparesis suffering a stroke.
To cope with the objective of the present study, RCT was conducted. Subjects who met inclusion criteria were recruited from a hospital rehabilitation unit. After the screening and signed consent, participants were randomly allocated to the control group or one of both experimental groups. NMES was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The electrostimulation protocols were only differentiated in the parameter of the stimulation frequency, 35 Hz or 50 Hz, depending on the experimental group to which the patient belonged to. Outcome measures were collected at the beginning, after 4 and 8 weeks of treatment, and after a follow-up period (4 weeks).
- Conditions
- Stroke
- Being tested
- Neuromuscular electrical stimulation
- Keywords
- Rehabilitation, Electric stimulation, Upper limb, Aging
- 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
| Study group | Role | What they receive |
|---|---|---|
| 50 Hz NMES group | Experimental | Neuromuscular electrical stimulation (NMES) was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The main electrostimulation parameters consisted of low-frequency current, a stimulation frequency of 50 Hz, symmetrical rectangular biphasic wave, and pulse duration of 300 μs. Receives: Other: Neuromuscular electrical stimulation |
| 35 Hz NMES group | Experimental | Neuromuscular electrical stimulation (NMES) was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The main electrostimulation parameters consisted of low-frequency current, a stimulation frequency of 35 Hz, symmetrical rectangular biphasic wave, and pulse duration of 300 μs. Receives: Other: Neuromuscular electrical stimulation |
| Control group | No intervention | Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion
A universal goniometer was used to measure the resting angle, active extension and passive extension of the wrist. A special JAMAR finger goniometer was used to evaluate the resting angle and active extension of the metacarpophalangeal joints of the fingers.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in dynamometric strength
The grip strength was assessed by means of a JAMAR hydraulic hand dynamometer and the pinch strength using the JAMAR hydraulic pinch gauge. Unit of measurement was kgf. Three repetitions were done in both evaluations, taking the highest value and leaving a resting period of 1 minute between them.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in muscle tone
Hypertonia of the finger and wrist flexors was measured using the modified Ashworth scale (MAS). MAS was used to categorize the severity of muscle tone by judging resistance to passive movement. It is a 6-point scale (0, 1, 1+ 2, 3, and 4) that ranges from 1 (=no increase in tone) to 4 (=limb rigid in flexion or extension). The assessment was started 5 minutes after laying the subject down in the supine position and using a single passive movement to evaluate each muscle group.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in functional motor ability
Manual dexterity was assessed by Box and block test.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Secondary outcomes (6)
Change in the mean electromyographic (EMG) amplitude
The Muscle Trainer model METR-0 (Mega Electronics Ltd, Kuopio, Finland) surface electromyograph was used. Circular adhesive surface bipolar electrodes (Ambú® Blue Sensor) were used and placed parallel to the muscle fibers. The mean amplitude of the EMG signal (in µV) of the muscle was recorded in the radial extensor and the radial flexor of the carpus. The patient was asked to perform maximum voluntary isometric contractions of both the flexors and extensors of the wrist for five seconds against manual resistance and the electrical activity of both the agonist and antagonist muscles was recorded simultaneously.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in the peak EMG amplitude
The Muscle Trainer model METR-0 (Mega Electronics Ltd, Kuopio, Finland) surface electromyograph was used. Circular adhesive surface bipolar electrodes (Ambú® Blue Sensor) were used and placed parallel to the muscle fibers. The peak amplitude of the EMG signal (in µV) of the muscle was recorded in the radial extensor and the radial flexor of the carpus. The patient was asked to perform maximum voluntary isometric contractions of both the flexors and extensors of the wrist for five seconds against manual resistance and the electrical activity of both the agonist and antagonist muscles was recorded simultaneously.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in the antagonist co-activation ratio
The Muscle Trainer model METR-0 (Mega Electronics Ltd, Kuopio, Finland) surface electromyograph was used. The antagonist co-activation ratio, both for the flexors and extensors of the wrist, was calculated using the following formula (antagonist activity/ [agonist activity + antagonist activity] x100%) (Reference: J Electromyogr Kinesiol. 2014;24:731-738) which provides an estimate of the relative activation of the agonist-antagonist muscle pair and also of the magnitude of the co-activation of the antagonist.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in kinaesthetic sensation
Hand kinaesthesia was assessed by the Revised Nottingham Sensory Assessment (RNSA) subscale. The RNSA includes three subscales: tactile sensation, kinesthetic sensation, and stereognosis. For kinesthetic sensation, all three aspects of the movement were tested: appreciation of movement, its direction, and accurate joint position sense. The limb on the affected side of the body was supported and moved by the examiner in various directions but the movement is only at one joint at a time. The patients were asked to mirror the change of movement with the other limb. This subscale ranges from 0 to 3. Higher scores indicate better kinaesthetic sensation.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in activities of daily living
A score of the Barthel Index ranging from 0 to 100 was collected where 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Change in health-related quality of life
COOP/WONCA charts were used. This instrument is a generic health status questionnaire which comprises nine single-item scales: physical fitness, feelings (mental well-being), daily activities, social activities, change in health and overall health, pain, social support, and quality of life. Each chart is rated on a five-point Likert scale with accompanying pictorial representations. Lower scores indicate better health-related quality of life.
Measured: The groups were assessed at baseline and 12 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study startJul 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trinidad Sentandreu-Mañó, University of Valencia
- Investigators
- Trinidad Sentandreu Mañó, PT, PhD, Principal investigator, University of ValenciaJ. Ricardo Salom Terrádez, MD, PhD, Study chair, Doctor Peset University HospitalJ. Manuel Tomas, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913624
- Sponsor's protocol ID
- 43/09
- Status last verified
- Apr 2019
- First submitted
- 9 Mar 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 35 Hz Versus 50 Hz Frequency Stimulation Effects on Motor Recovery in Older Adults After Stroke. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03913624
- Acronym / sponsor ID
- 43/09
- Conditions
- Stroke
- Keywords
- Rehabilitation, Electric stimulation, Upper limb, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Apr 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.
A Randomized Clinical Trial (RCT) was conducted to determine the effects of two neuromuscular electrical stimulation protocols with different stimulation frequencies on motor recovery in older adults with spastic hemiparesis after a stroke.
Detailed description
Impairment of the upper limb is one of the most frequent consequences of stroke and directly impacts on the patient's functional status and quality of life. It is estimated that less than 50% of stroke survivors will recover arm function, which will exert a great economic, social and personal toll.
Neuromuscular electrical stimulation (NMES) is one of the techniques suggested for upper limb recovery in stroke patients. However, after considering the bibliographic background, more studies are required in order to test its effectiveness, to establish the most efficient NMES protocols and to assess the characteristics of the patients who can benefit the most from this treatment. With this regard, the parameters of the stimulation are currently subject to debate, and more data are needed to optimize the application of this treatment. The aim of this study was to evaluate and compare the effects of two neuromuscular electrical stimulation protocols with different stimulation frequencies on motor impairment, kinaesthetic sensation, functional motor ability, activities of daily living, and quality of life in older adults with spastic hemiparesis suffering a stroke.
To cope with the objective of the present study, RCT was conducted. Subjects who met inclusion criteria were recruited from a hospital rehabilitation unit. After the screening and signed consent, participants were randomly allocated to the control group or one of both experimental groups. NMES was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The electrostimulation protocols were only differentiated in the parameter of the stimulation frequency, 35 Hz or 50 Hz, depending on the experimental group to which the patient belonged to. Outcome measures were collected at the beginning, after 4 and 8 weeks of treatment, and after a follow-up period (4 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 Hz NMES group | Experimental | Other: Neuromuscular electrical stimulationNeuromuscular electrical stimulation (NMES) was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The main electrostimulation parameters consisted of low-frequency current, a stimulation frequency of 50 Hz, symmetrical rectangular biphasic wave, and pulse duration of 300 μs. |
| 35 Hz NMES group | Experimental | Other: Neuromuscular electrical stimulationNeuromuscular electrical stimulation (NMES) was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The main electrostimulation parameters consisted of low-frequency current, a stimulation frequency of 35 Hz, symmetrical rectangular biphasic wave, and pulse duration of 300 μs. |
| Control group | No intervention | –Conventional treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 60 years
- Post-stroke spastic hemiparesis
- Mild-moderate hand impairment
- A score ≤ 3 on the modified Ashworth scale for wrist and finger flexors
- Active wrist extension ≥ 5º from the resting position
Key exclusion criteria (14 listed)
- Previous hemiparesis due to stroke
- Dermatological reactions with the application of stimulation
- Significant sensory deficits in the affected arm
- Previous musculoskeletal problems of the hand
- Treatment with the botulin toxin
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 stimulation | Other | 35 Hz NMES group, 50 Hz NMES group |
Primary outcome
Change in range of motion
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
A universal goniometer was used to measure the resting angle, active extension and passive extension of the wrist. A special JAMAR finger goniometer was used to evaluate the resting angle and active extension of the metacarpophalangeal joints of the fingers.
Change in dynamometric strength
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
The grip strength was assessed by means of a JAMAR hydraulic hand dynamometer and the pinch strength using the JAMAR hydraulic pinch gauge. Unit of measurement was kgf. Three repetitions were done in both evaluations, taking the highest value and leaving a resting period of 1 minute between them.
Change in muscle tone
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Hypertonia of the finger and wrist flexors was measured using the modified Ashworth scale (MAS). MAS was used to categorize the severity of muscle tone by judging resistance to passive movement. It is a 6-point scale (0, 1, 1+ 2, 3, and 4) that ranges from 1 (=no increase in tone) to 4 (=limb rigid in flexion or extension). The assessment was started 5 minutes after laying the subject down in the supine position and using a single passive movement to evaluate each muscle group.
Change in functional motor ability
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Manual dexterity was assessed by Box and block test.
6 secondary outcomes
Change in the mean electromyographic (EMG) amplitude
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Change in the peak EMG amplitude
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Change in the antagonist co-activation ratio
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Change in kinaesthetic sensation
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Change in activities of daily living
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Change in health-related quality of life
Time frame: The groups were assessed at baseline and 12 weeks post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
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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.
Trinidad Sentandreu Mañó, PT, PhD principal investigator
University of Valencia
J. Ricardo Salom Terrádez, MD, PhD study chair
Doctor Peset University Hospital
J. Manuel Tomas, PhD study chair
University of Valencia
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, run by University of Valencia at 1 site in Spain.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 12 Apr 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in range of motion (time frame: The groups were assessed at baseline and 12 weeks post-intervention.). The study lists 4 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 12 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.