StrokeNCT06725069
Effects of Neuromuscular Electrical Stimulation on Flexor Spasticity and Function in Stroke Patients
An observational study of Stroke and Spastic Hemiplegia, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to determine the effects of botulinum neurotoxin type A injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke, Spastic Hemiplegia
- What is being tested?
- Neuromuscular Electrical Stimulation
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 14 Jan 2025
- Phase
- Observational
- 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
Study population: Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
Who may be able to join
- Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
- First time stroke survivor
- between 45-75 years old
- Stroke duration > 3 months
- Neurologically stable
- Affected wrist and finger flexor muscle spasticity with MAS≥2
- Patients whose cognitive status is at a level to understand the study instructions MMT> 23)
Who cannot join
- Presence of another neurological disorder other than stroke causing motor impairment/spasticity
- Fixed contracture in the hand-wrist
- Use of medical treatment for spasticity
- Having received neurolytic therapy, BoNT-A injection or NMES treatment in the last 3 months
- Skin problem (disease, allergy, infection, etc.) on the contact surface of the NMES
- Complex regional pain syndrome (CRPS), sequelae of previous trauma or surgery (muscle tendon adhesion, peripheral nerve damage) in the affected extremity
Show all 9Show fewer
- Having a pacemaker
- Epilepsy
- Malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Ankara, Ankara
About this study
Official title: Effects of Neuromuscular Electrical Stimulation Applied to Agonist or Antagonist Muscles of the Upper Extremity on Flexor Spasticity and Function in Patients With Stroke
In this study, the investigators aimed to determine the effects of botulinum neurotoxin type A injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients.
Read the detailed description
Neuromuscular electrical stimulation therapy applied to wrist and finger flexors (agonist application) or wrist and finger extensors (antagonist application) after botulinum neurotoxin type A injections in stroke patients with wrist and finger flexor spasticity in upper extremity flexor spasticity, To determine the effects on motor recovery, upper extremity and hand functions, hand grip strength, range of motion, functional independence, quality of life, hand skills and sonographically evaluated muscle thickness and to compare these different applications.
- Conditions
- Stroke, Spastic Hemiplegia
- Being tested
- Neuromuscular Electrical Stimulation, Control (Standard treatment)
- Keywords
- stroke, neuromuscular electrical stimulation, rehabilitation, hemiplegia, spasticity
- Medical subject headings
- Stroke, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationOther
NMES was performed using the Enraf Nonius Myomed 632X device. Both applications were performed 5 days/week for 4 weeks. NMES was performed with the patients in a sitting position and the affected arm resting on a table with the forearm supinated (Agonist group) / forearm pronated (Antagonist group). Surface electrodes (50x50 mm self-adhesive) were placed on the wrist and finger flexor/extensor muscle group. NMES parameters; Symmetric biphasic, pulse width 200 μs, on time 6 seconds (ramp up 1 second, ramp down 2 seconds), off time 12 seconds, stimulation intensity according to the patient's tolerance (not exceeding 90 mA), frequency 50 Hz and was adjusted to elicit contraction in the flexor and extensor muscles of the wrist and fingers.
Control (Standard treatment)Other
In addition to conventional treatment, participants were included in an occupational rehabilitation program for 20 minutes to improve upper extremity functions.
| Study group | Role | What they receive |
|---|---|---|
| Agonist NMES | In the first group, NMES (Group 1=Agonist group) was applied to the wrist and finger flexors for 20 minutes in addition to conventional treatment. Receives: Other: Neuromuscular Electrical Stimulation | |
| Antagonist NMES | In the second group, NMES (Group 2=Antagonist group) was applied to the wrist and finger extensors for 20 minutes in addition to conventional treatment. Receives: Other: Neuromuscular Electrical Stimulation | |
| Exercise | Patients in the third group (Group 3=Control group) were included in an occupational rehabilitation program for 20 minutes to improve upper extremity functions in addition to conventional treatment. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a clinical tool used to assess spasticity, which is characterized by increased muscle tone and resistance to passive movement. It is commonly applied in individuals with neurological conditions such as stroke, multiple sclerosis, or cerebral palsy. The scale involves passively moving a limb through its range of motion and evaluating the resistance felt. The scoring ranges from 0 to 4, where 0 indicates no increase in muscle tone, 1 represents a slight increase with a catch or minimal resistance at the end of the range, and 1+ reflects a catch followed by minimal resistance through less than half of the movement. A score of 2 denotes a more marked increase in tone through most of the range, but the limb remains movable. 3 indicates considerable resistance, making movement difficult, and 4 signifies a rigid limb with severe spasticity. This scale is widely used in rehabilitation to monitor spasticity and guide treatment interventions.
Measured: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).
Brunnstrom
The Brunnstrom Stages of Recovery describe the six stages of motor recovery following a stroke or brain injury. In Stage 1, there is flaccidity, with no voluntary movement or reflex activity in the affected limb. Stage 2 marks the beginning of spasticity, with the emergence of basic limb synergies and minimal voluntary movement. In Stage 3, spasticity reaches its peak, and voluntary control is limited to synergy patterns. Stage 4 involves a decrease in spasticity, with the appearance of some voluntary movements outside of synergy patterns. By Stage 5, spasticity continues to decline, and more complex and isolated movements become possible. Finally, in Stage 6, normal movement patterns are largely restored, with minimal or no spasticity and full control of isolated joint movements.
Measured: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Feb 2024
- Primary completion31 Oct 2024
- Study completion14 Jan 2025
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Karaduman, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Eda Gürçay, Prof., Study director, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725069
- Sponsor's protocol ID
- E2-24-9437
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation Applied to Agonist or Antagonist Muscles of the Upper Extremity on Flexor Spasticity and Function in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06725069
- Acronym / sponsor ID
- E2-24-9437
- Conditions
- Stroke, Spastic Hemiplegia
- Keywords
- stroke, neuromuscular electrical stimulation, rehabilitation, hemiplegia, spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 10 Dec 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.
In this study, the investigators aimed to determine the effects of botulinum neurotoxin type A injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients.
Detailed description
Neuromuscular electrical stimulation therapy applied to wrist and finger flexors (agonist application) or wrist and finger extensors (antagonist application) after botulinum neurotoxin type A injections in stroke patients with wrist and finger flexor spasticity in upper extremity flexor spasticity, To determine the effects on motor recovery, upper extremity and hand functions, hand grip strength, range of motion, functional independence, quality of life, hand skills and sonographically evaluated muscle thickness and to compare these different applications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Agonist NMES | – | Other: Neuromuscular Electrical StimulationIn the first group, NMES (Group 1=Agonist group) was applied to the wrist and finger flexors for 20 minutes in addition to conventional treatment. |
| Antagonist NMES | – | Other: Neuromuscular Electrical StimulationIn the second group, NMES (Group 2=Antagonist group) was applied to the wrist and finger extensors for 20 minutes in addition to conventional treatment. |
| Exercise | – | Other: Control (Standard treatment)Patients in the third group (Group 3=Control group) were included in an occupational rehabilitation program for 20 minutes to improve upper extremity functions in addition to conventional treatment. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
Key inclusion criteria (7 listed)
- Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
- First time stroke survivor
- between 45-75 years old
- Stroke duration > 3 months
- Neurologically stable
Key exclusion criteria (9 listed)
- Presence of another neurological disorder other than stroke causing motor impairment/spasticity
- Fixed contracture in the hand-wrist
- Use of medical treatment for spasticity
- Having received neurolytic therapy, BoNT-A injection or NMES treatment in the last 3 months
- Skin problem (disease, allergy, infection, etc.) on the contact surface of the NMES
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 StimulationNMES was performed using the Enraf Nonius Myomed 632X device. Both applications were performed 5 days/week for 4 weeks. NMES was performed with the patients in a sitting position and the affected arm resting on a table with the forearm supinated (Agonist group) / forearm pronated (Antagonist group). Surface electrodes (50x50 mm self-adhesive) were placed on the wrist and finger flexor/extensor muscle group. NMES parameters; Symmetric biphasic, pulse width 200 μs, on time 6 seconds (ramp up 1 second, ramp down 2 seconds), off time 12 seconds, stimulation intensity according to the patient's tolerance (not exceeding 90 mA), frequency 50 Hz and was adjusted to elicit contraction in the flexor and extensor muscles of the wrist and fingers. | Other | Agonist NMES, Antagonist NMES |
| Control (Standard treatment)In addition to conventional treatment, participants were included in an occupational rehabilitation program for 20 minutes to improve upper extremity functions. | Other | Exercise |
Primary outcome
The Modified Ashworth Scale (MAS)
Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).
The Modified Ashworth Scale (MAS) is a clinical tool used to assess spasticity, which is characterized by increased muscle tone and resistance to passive movement. It is commonly applied in individuals with neurological conditions such as stroke, multiple sclerosis, or cerebral palsy. The scale involves passively moving a limb through its range of motion and evaluating the resistance felt. The scoring ranges from 0 to 4, where 0 indicates no increase in muscle tone, 1 represents a slight increase with a catch or minimal resistance at the end of the range, and 1+ reflects a catch followed by minimal resistance through less than half of the movement. A score of 2 denotes a more marked increase in tone through most of the range, but the limb remains movable. 3 indicates considerable resistance, making movement difficult, and 4 signifies a rigid limb with severe spasticity. This scale is widely used in rehabilitation to monitor spasticity and guide treatment interventions.
Brunnstrom
Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).
The Brunnstrom Stages of Recovery describe the six stages of motor recovery following a stroke or brain injury. In Stage 1, there is flaccidity, with no voluntary movement or reflex activity in the affected limb. Stage 2 marks the beginning of spasticity, with the emergence of basic limb synergies and minimal voluntary movement. In Stage 3, spasticity reaches its peak, and voluntary control is limited to synergy patterns. Stage 4 involves a decrease in spasticity, with the appearance of some voluntary movements outside of synergy patterns. By Stage 5, spasticity continues to decline, and more complex and isolated movements become possible. Finally, in Stage 6, normal movement patterns are largely restored, with minimal or no spasticity and full control of isolated joint movements.
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 2 Apr 2025.
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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.
Eda Gürçay, Prof. study director
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Spastic Hemiplegia, run by Gaziler Physical Medicine and Rehabilitation Education and Research 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 7 inclusion and 9 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 2 Apr 2025. 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. 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?
The Modified Ashworth Scale (MAS) (time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).). 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 2 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.