StrokeTENS NMESNCT06619262
Concomitant Application of TENS and NMES on Chronic Stroke
A study testing Transcutaneous Electrical Nerve Stimulation, Neuromuscular and Muscular Electrical Stimulation and Exercise program in people with Stroke and Hemiparesis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life. Chronic stroke patients often experience decreased balance control, which negatively affects activities of daily living and their ability to walk independently. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation, Neuromuscular and Muscular Electrical Stimulation and Exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 31 Jan 2024
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First episode of unilateral stroke with hemiparesis Stroke confirmed by CT and/or MRI Ablity to independently stand up from a chair
Who cannot join
- Cerebellar or brainstem stroke Severe cognitive and communication impairment Previous surgical treatment history on the affected extremity Complication with severe heart, lung, liver, kidney, or infectious disease Presence of a cardiac pacemaker Orthopedic disease affecting sit-to-stand movement Inability to understand and follow verbal commands Peripheral or central nervous system dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Concomitant Application of TENS and NMES on Chronic Stroke Patients: A Prospective Randomized Controlled Study
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life. Chronic stroke patients often experience decreased balance control, which negatively affects activities of daily living and their ability to walk independently. Studies conducted with electrical stimulation have shown that it is safe to use on humans. Today, it is frequently preferred in treatment.
Electrical stimulation are effective for treatment of stroke. Electrical stimulation has been used as transcutaneous nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). Both of them are effective but not sufficient. The concomitant application of TENS and NMES may achieve better results than individually application.
Read the detailed description
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life. Chronic stroke patients often experience decreased balance control, which negatively affects activities of daily living and their ability to walk independently. The most recognized impairments are deficits in motor control and limited mobility. Chronic stroke patients may develop spasticity, which is the main cause of decreased balance and gait. The rate of post-stroke spasticity is 4 - 27% in the 6th week, increasing to 42.6% by the 6th month. Electrical stimulation has been used in numerous studies to decrease spasticity.
Electrical stimulation has been widely used in stroke rehabilitation, including transcutaneous nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). NMES is an effective and conventional therapeutic method for improving motor function in patients with lower extremity paralysis after stroke. During NMES, current pulses are applied to the muscles or motor nerves through surface electrodes to induce muscle contractions to mimic exercise therapy. NMES can help improve muscle strength, joint range of motion, and promote motor relearning. TENS, another electrical stimulation, is used to relieve pain, improve muscle strength and motor function, and reduce spasticity through transdermal output pulses. The motor recovery mechanism of TENS involves the presynaptic inhibition of the hyperactive stretch reflexes in spastic muscles and decreased co-contraction of the spastic antagonist muscles.
Numerous studies have investigated the benefits of TENS or NMES applied to the lower extremities. These studies have revealed that both forms of electric stimulation are effective in the recovery of chronic stroke patients.
However, there is no comparative study on the effect of TENS and NMES applied individually versus their concomitant application. The combined application of TENS and NMES may yield better results. The aim of this study is to compare the effects of TENS and NMES, applied both individually and concomitantly, on posture, lower extremity motor recovery, functional independence, motor function recovery, and spasticity. Hypothesis is that the concomitant application of TENS and NMES will achieve better results than individually application.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Transcutaneous Electrical Nerve Stimulation, Neuromuscular and Muscular Electrical Stimulation, Exercise program
- Keywords
- Stroke, Exercise program, TENS, NMES
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
TENS stands for transcutaneous electrical nerve stimulation. Transcutaneous means across the skin. TENS machines pass a small electrical current across your skin to stimulate the nerves.
Neuromuscular and Muscular Electrical StimulationDevice
Neuromuscular and Muscular Electrical Stimulation (NMES) is a modality that sends electrical impulses to nerves which causes the muscles to contract mimicking the action potential coming from the central nervous system.
Exercise programOther
Specific exercise program for patients with lower extremity hemiparesis after stroke
| Study group | Role | What they receive |
|---|---|---|
| TENS+NMES Group | Experimental | The group in which TENS and NMES are applied concomitantly in the treatment Receives: Device: Transcutaneous Electrical Nerve Stimulation; Device: Neuromuscular and Muscular Electrical Stimulation; Other: Exercise program |
| TENS Group | Active comparator | The group in which TENS is applied concomitantly in the treatment Receives: Device: Transcutaneous Electrical Nerve Stimulation; Other: Exercise program |
| NMES Group | Active comparator | The group in which NMES is applied concomitantly in the treatment Receives: Device: Neuromuscular and Muscular Electrical Stimulation; Other: Exercise program |
| Control | Sham comparator | No additional electrical stimulation is applied for treatment in this group. Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale
Disability caused by stroke was evaluated using the National Institutes of Health Stroke Scale (NIHSS). The following domains were assessed with the NIHSS: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Evaluation was based on a total score ranging from 0 to 42, with higher the scores indicating more severe stroke.
Measured: up to 4 months
Brunnstrom's Hemiplegia Recovery Staging
The lower extremity motor recovery was assessed using Brunnstrom's Hemiplegia Recovery Staging. There are six grades in Brunnstrom's Hemiplegia Recovery Staging for the lower extremity. A higher stage indicates better motor function. The Brunnstrom stages were preferred because they reflect the underlying motor control based on clinical assessment of movement quality.
Measured: up to 4 months
Postural Assessment Scale for Stroke Patients
Postural Assessment Scale for Stroke Patients (PASS) was developed specifically for evaluating balance in stroke patients. PASS contains two subheadings for evaluating balance: maintaining posture (static PASS) and changing posture (dynamic PASS). It consists of 12 items to evaluate balance: 5 items (sitting without support; standing with support; standing without support; standing on the non-paretic leg; standing on the paretic leg) for static PASS, and 7 items (supine to affected side lateral; supine to non-affected side lateral; supine to sitting up on the edge of the mat; sitting on the edge of the mat to supine; sitting to standing; standing to sitting down; standing, picking up a pencil from the floor) for dynamic PASS. Evaluation was based on a total score ranging from 0 to 36, with higher the scores indicating more favorable balance in stroke patients.
Measured: up to 4 months
Functional Independence Measures
Functional Independence Measures (FIM) is widely used to assess the independence of stroke patients. It contains 18 items under the following categories: self-care, sphincter control, transfers, locomotion, communication and social cognition. Each item was scored from 1 to 7, with 7 indicating complete independence and 1 indicating complete dependence. Scores below 6 indicate that the patient requires assistance or supervision from another person.
Measured: up to 4 months
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) was used to assess the spasticity of the ankle plantar flexors. The physiotherapist passively moved the ankle from maximal plantarflexion to maximal dorsiflexion. The MAS assigns a grade of spasticity on a scale of 0-4 based on the level of resistance in response to passive movement. A score of 0 represents no increase in muscle tone, while a score of 4 represents rigidity of the affected part in flexion or extension.
Measured: up to 4 months
Secondary outcomes (1)
Electrical stimulation side effects
Skin lesions, muscle cramps or ruptures, and neurovascular side effects that may occur with the combined application of TENS and NMES will be evaluated.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Nov 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Why it stopped: After the G power analysis, it was determined that a total of 60 patients needed initial, 1st month and 4th month follow-ups. The study was terminated when the follow-ups of 60 patients were completed prospectively.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized assessor-blind comparison study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Betül Başar, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619262
- Sponsor's protocol ID
- University of Health Sciences
- Acronym
- TENS NMES
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Basar B, Alp OF. The effects of concomitant application of TENS and NMES on chronic stroke patients: a prospective randomized controlled study. BMC Sports Sci Med Rehabil. 2025 Apr 24;17(1):91. doi: 10.1186/s13102-025-01155-w.
PubMed 40275398
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Concomitant Application of TENS and NMES on Chronic Stroke Patients: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06619262
- Acronym / sponsor ID
- TENS NMES / University of Health Sciences
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Exercise program, TENS, NMES
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After the G power analysis, it was determined that a total of 60 patients needed initial, 1st month and 4th month follow-ups. The study was terminated when the follow-ups of 60 patients were completed prospectively.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 1 Oct 2024 (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.
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life. Chronic stroke patients often experience decreased balance control, which negatively affects activities of daily living and their ability to walk independently. Studies conducted with electrical stimulation have shown that it is safe to use on humans. Today, it is frequently preferred in treatment.
Electrical stimulation are effective for treatment of stroke. Electrical stimulation has been used as transcutaneous nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). Both of them are effective but not sufficient. The concomitant application of TENS and NMES may achieve better results than individually application.
Detailed description
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life. Chronic stroke patients often experience decreased balance control, which negatively affects activities of daily living and their ability to walk independently. The most recognized impairments are deficits in motor control and limited mobility. Chronic stroke patients may develop spasticity, which is the main cause of decreased balance and gait. The rate of post-stroke spasticity is 4 - 27% in the 6th week, increasing to 42.6% by the 6th month. Electrical stimulation has been used in numerous studies to decrease spasticity.
Electrical stimulation has been widely used in stroke rehabilitation, including transcutaneous nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). NMES is an effective and conventional therapeutic method for improving motor function in patients with lower extremity paralysis after stroke. During NMES, current pulses are applied to the muscles or motor nerves through surface electrodes to induce muscle contractions to mimic exercise therapy. NMES can help improve muscle strength, joint range of motion, and promote motor relearning. TENS, another electrical stimulation, is used to relieve pain, improve muscle strength and motor function, and reduce spasticity through transdermal output pulses. The motor recovery mechanism of TENS involves the presynaptic inhibition of the hyperactive stretch reflexes in spastic muscles and decreased co-contraction of the spastic antagonist muscles.
Numerous studies have investigated the benefits of TENS or NMES applied to the lower extremities. These studies have revealed that both forms of electric stimulation are effective in the recovery of chronic stroke patients.
However, there is no comparative study on the effect of TENS and NMES applied individually versus their concomitant application. The combined application of TENS and NMES may yield better results. The aim of this study is to compare the effects of TENS and NMES, applied both individually and concomitantly, on posture, lower extremity motor recovery, functional independence, motor function recovery, and spasticity. Hypothesis is that the concomitant application of TENS and NMES will achieve better results than individually application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a prospective randomized assessor-blind comparison study.
| Arm | Type | Receives |
|---|---|---|
| TENS+NMES Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation, Device: Neuromuscular and Muscular Electrical Stimulation, Other: Exercise programThe group in which TENS and NMES are applied concomitantly in the treatment |
| TENS Group | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation, Other: Exercise programThe group in which TENS is applied concomitantly in the treatment |
| NMES Group | Active comparator | Device: Neuromuscular and Muscular Electrical Stimulation, Other: Exercise programThe group in which NMES is applied concomitantly in the treatment |
| Control | Sham comparator | Other: Exercise programNo additional electrical stimulation is applied for treatment in this group. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First episode of unilateral stroke with hemiparesis Stroke confirmed by CT and/or MRI Ablity to independently stand up from a chair
Key exclusion criteria (1 listed)
- Cerebellar or brainstem stroke Severe cognitive and communication impairment Previous surgical treatment history on the affected extremity Complication with severe heart, lung, liver, kidney, or infectious disease Presence of a cardiac pacemaker Orthopedic disease affecting sit-to-stand movement Inability to understand and follow verbal commands Peripheral or central nervous system dysfunction
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 |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationTENS stands for transcutaneous electrical nerve stimulation. Transcutaneous means across the skin. TENS machines pass a small electrical current across your skin to stimulate the nerves. | Device | TENS Group, TENS+NMES Group |
| Neuromuscular and Muscular Electrical StimulationNeuromuscular and Muscular Electrical Stimulation (NMES) is a modality that sends electrical impulses to nerves which causes the muscles to contract mimicking the action potential coming from the central nervous system. | Device | NMES Group, TENS+NMES Group |
| Exercise programSpecific exercise program for patients with lower extremity hemiparesis after stroke | Other | Control, NMES Group, TENS Group, TENS+NMES Group |
Primary outcome
National Institutes of Health Stroke Scale
Time frame: up to 4 months
Disability caused by stroke was evaluated using the National Institutes of Health Stroke Scale (NIHSS). The following domains were assessed with the NIHSS: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Evaluation was based on a total score ranging from 0 to 42, with higher the scores indicating more severe stroke.
Brunnstrom's Hemiplegia Recovery Staging
Time frame: up to 4 months
The lower extremity motor recovery was assessed using Brunnstrom's Hemiplegia Recovery Staging. There are six grades in Brunnstrom's Hemiplegia Recovery Staging for the lower extremity. A higher stage indicates better motor function. The Brunnstrom stages were preferred because they reflect the underlying motor control based on clinical assessment of movement quality.
Postural Assessment Scale for Stroke Patients
Time frame: up to 4 months
Postural Assessment Scale for Stroke Patients (PASS) was developed specifically for evaluating balance in stroke patients. PASS contains two subheadings for evaluating balance: maintaining posture (static PASS) and changing posture (dynamic PASS). It consists of 12 items to evaluate balance: 5 items (sitting without support; standing with support; standing without support; standing on the non-paretic leg; standing on the paretic leg) for static PASS, and 7 items (supine to affected side lateral; supine to non-affected side lateral; supine to sitting up on the edge of the mat; sitting on the edge of the mat to supine; sitting to standing; standing to sitting down; standing, picking up a pencil from the floor) for dynamic PASS. Evaluation was based on a total score ranging from 0 to 36, with higher the scores indicating more favorable balance in stroke patients.
Functional Independence Measures
Time frame: up to 4 months
Functional Independence Measures (FIM) is widely used to assess the independence of stroke patients. It contains 18 items under the following categories: self-care, sphincter control, transfers, locomotion, communication and social cognition. Each item was scored from 1 to 7, with 7 indicating complete independence and 1 indicating complete dependence. Scores below 6 indicate that the patient requires assistance or supervision from another person.
Modified Ashworth Scale
Time frame: up to 4 months
The Modified Ashworth Scale (MAS) was used to assess the spasticity of the ankle plantar flexors. The physiotherapist passively moved the ankle from maximal plantarflexion to maximal dorsiflexion. The MAS assigns a grade of spasticity on a scale of 0-4 based on the level of resistance in response to passive movement. A score of 0 represents no increase in muscle tone, while a score of 4 represents rigidity of the affected part in flexion or extension.
1 secondary outcome
Electrical stimulation side effects
Time frame: up to 4 months
Results and safety
The study was stopped early (reason given: After the G power analysis, it was determined that a total of 60 patients needed initial, 1st month and 4th month follow-ups. The study was terminated when the follow-ups of 60 patients were completed prospectively.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 40275398Basar B, Alp OF. The effects of concomitant application of TENS and NMES on chronic stroke patients: a prospective randomized controlled study. BMC Sports Sci Med Rehabil. 2025 Apr 24;17(1):91. doi: 10.1186/s13102-025-01155-w.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation, Neuromuscular and Muscular Electrical Stimulation and Exercise program in people with Stroke and Hemiparesis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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: stopped early, as of the sponsor's last update on 1 Oct 2024. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: After the G power analysis, it was determined that a total of 60 patients needed initial, 1st month and 4th month follow-ups. The study was terminated when the follow-ups of 60 patients were completed prospectively.). Results are not available in the source record.
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?
National Institutes of Health Stroke Scale (time frame: up to 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06619262, which also lists 1 linked publication.
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 Oct 2024.