Post-Stroke SpasticityNCT07617311
Effect of NMES on Spasticity
A study testing Neuromuscular electrical stimulation (NMES) in people with Post-Stroke Spasticity, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if neuromuscular electrical stimulation (NMES) works to treat spasticity in adult patients with spasticity related to stroke. The main question it aims to answer is: Does NMES reduces the severity of spasticity? Researchers will compare NMES treatment to baseline and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Stroke Spasticity
- What is being tested?
- Neuromuscular electrical stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 16 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Post-stroke wrist flexor spasticity scored as Grade 2 or 3 on the Australian Spasticity Assessment Scale (ASAS), specifically selecting patients whose passive stretch resistance (post-catch response) can be easily overcome to ensure accurate and unconfounded electrophysiological evaluation.
- Provision of voluntary, written informed consent prior to study enrollment.
Who cannot join
- Age <18 or >70 year
- Contraindications to neuromuscular electrical stimulation (e.g., active electronic implants, history of epilepsy, or localized skin lesions preventing electrode placement)
- Concomitant wrist contracture or pain sufficient to impede clinical evaluation
- Structural abnormalities of the elbow joint obstructing median nerve stimulation
- Median nerve neuropathy or injury in the ipsilateral upper extremity.
- Non-stable dosage of antispastic medications within the 2 weeks prior to baseline
Show all 13Show fewer
- Initiation of medications affecting nerve conduction (e.g., antidepressants, anticonvulsants, anesthetics) within the past month; patients on a stable dose for >1 month remain eligible
- Botulinum toxin infiltration in the target spastic muscles within the preceding 3 months
- History of neurolytic procedures targeting spasticity in the affected limb.
- History of orthopedic or neurological surgery targeting spasticity in the affected limb
- Cognitive impairment severe enough to compromise adherence to study protocols
- Inability to maintain the required testing positions for the upper extremity joints (shoulder, elbow, forearm, and wrist)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University
Izmir, Karabağlar, 35150
İlker Şengül, M.D., +905337333698, ilkrsngl@gmail.com
Aleyna Uğurlu, M.D., +905433466277, aleynaugurlu2000@gmail.com
About this study
Official title: The Effect of Neuromuscular Electrical Stimulation on Spasticity: A Single-Subject Experimental Study
The goal of this clinical trial is to learn if neuromuscular electrical stimulation (NMES) works to treat spasticity in adult patients with spasticity related to stroke. The main question it aims to answer is:
- Does NMES reduces the severity of spasticity? Researchers will compare NMES treatment to baseline and non-stimulation periods to see if NMES works to treat spasticity.
Read more
Participants will:
- first undergo an initial assessment at 10-minute intervals for one hour, followed by 20 minutes of NMES exposure, and subsequent post-treatment assessments at 10-minute intervals for two hours. This daily procedure will be repeated over four days for one patient, and performed only once for the remaining three patients.
Read the detailed description
Spasticity is a sensory-motor control disorder arising from upper motor neuron lesions, affecting approximately 97% of chronic stroke patients presenting with moderate-to-severe motor impairment. This pathology is driven by stretch reflex hyperexcitability, stemming from secondary alterations in the supraspinal, spinal interneuronal, and striated muscle systems; it manifests as an exaggerated reflex response to peripheral stimuli and concomitant excessive muscle activity. While several definitions exist in the literature, the operational conceptualization of spasticity as 'the enhancement of velocity-dependent stretch reflexes, measured at rest' establishes it as a highly quantifiable and robust target variable for clinical evaluation and scientific investigation.
Spasticity management encompasses diverse therapeutic modalities, ranging from pharmacological to non-pharmacological approaches. Among these, neuromuscular electrical stimulation (NMES) has emerged as a prominent intervention. Although documented as a beneficial adjunctive therapy, the clinical translation of NMES from randomized controlled trials to bedside practice is frequently hindered by marked study heterogeneity and a scarcity of high-quality evidence. Moreover, despite its clinical adoption, NMES application parameters remain largely unstandardized, and substantial inter-individual variability precludes the direct extrapolation of group-level averages to individual patients. Therefore, rigorous experimental frameworks capable of generating robust, individual-level scientific evidence are required to guide real-world practice and optimize personalized therapeutic decisions. Within this paradigm, single-subject experimental designs represent a highly promising methodological approach.
Consequently, this study investigates the therapeutic efficacy of NMES on spasticity among chronic stroke patients with spastic paresis lasting longer than one year, utilizing single-subject experimental methodologies-specifically withdrawal/reversal and multiple-baseline designs. To achieve this, this research addresses four primary objectives: evaluating whether standalone NMES reduces spasticity severity; determining the longevity of any observed therapeutic effect; quantifying the precise magnitude of this intervention; and examining the generalizability of the outcomes. Framed within the context of the experimental design-analysis paradigm, we hypothesize that isolated NMES application will significantly reduce spasticity. This hypothesis will be systematically tested across three distinct stages. The initial pilot stage will delineate the presence, magnitude, and duration of NMES efficacy using predefined stimulation parameters. Subsequently, the second stage will implement a withdrawal/reversal design with built-in wash-out periods to provide robust causal evidence regarding NMES outcomes. Finally, the third stage will deploy a multiple-baseline design across participants to establish the generalizability of the intervention parameters.
In the first stage, a basic phase-change (A-B) design will be applied to a single participant, where Phase A represents the untreated baseline period, and Phase B denotes the NMES application followed immediately by post-treatment assessments. Specifically, the participant will undergo a baseline assessment at 10-minute intervals for one hour, followed by a 20-minute NMES application, and subsequent post-treatment assessments at 10-minute intervals for two hours. This initial stage serves as a pilot phase designed to evaluate potential NMES-related effects, and progression to Stage 2 will occur independently of the treatment's efficacy status during this pilot.
In the second stage, this daily procedure is planned to be repeated over four consecutive days separated by washout intervals for the same participant, yielding a full A-B-A-B-A-B-A sequence. However, the study incorporates a strict ethical stopping rule: if visual analysis reveals no positive clinical response by the end of the second day (concluding the initial A-B-A-B phases), the protocol will be discontinued immediately due to futility, and the study will not proceed to the final stage. Conversely, if a positive response is verified visually, the full four-day sequence will be completed, and a non-concurrent multiple baseline design across participants (the final stage) will subsequently be implemented.
In the final stage, the single-day (A-B) procedure will be applied only once to three additional participants. To ensure methodological rigor, the baseline lengths for these three participants will consist of 5, 7, and 9 assessments, respectively, assigned in a randomized order.
- Conditions
- Post-Stroke Spasticity
- Being tested
- Neuromuscular electrical stimulation (NMES)
- Keywords
- Post-stroke spasticity, Neuromuscular electrical stimulation, Muscle reaction angle, H reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES)Device
Neuromuscular electrical stimulation (NMES) (a symmetric, biphasic, rectangular waveform) will be administered to the antagonist wrist extensors (extensor carpi radialis longus/brevis and extensor carpi ulnaris) of the spastic wrist flexors in the B phase. The configuration consists of an application duration of 20 minutes, a stimulation frequency of 35 Hz, and a pulse duration of 300 μs. The duty cycle will feature a 20-second ON time and 20-second OFF time (1:1 ratio), with ramp-up and ramp-down durations set at 5 seconds.
Neuromuscular electrical stimulation (NMES)Device
Neuromuscular electrical stimulation (NMES) is a therapeutic modality used in neurorehabilitation. By delivering transcutaneous electrical currents, NMES elicits repetitive, patterned muscle contractions to augment or restore motor functions.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) | Experimental | Neuromuscular electrical stimulation (NMES) (a symmetric, biphasic, rectangular waveform) will be administered to the antagonist wrist extensors (extensor carpi radialis longus/brevis and extensor carpi ulnaris) of the spastic wrist flexors in the B (intervention) phase. The configuration consists of an application duration of 20 minutes, a stimulation frequency of 35 Hz, and a pulse duration of 300 μs. The duty cycle will feature a 20-second ON time and 20-second OFF time (1:1 ratio), with ramp-up and ramp-down durations set at 5 seconds. During Phase A, no intervention will be carried out Receives: Device: Neuromuscular electrical stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of Muscle Reaction
The Angle of Muscle Reaction is the specific joint angle at which a catch response is elicited in the target muscles (flexor carpi radialis and flexor carpi ulnaris) during a passive stretch delivered at the highest possible velocity.
Measured: From enrollment up to 1 day (Stages 1 and 3) or 2 to 4 days (Stage 2), depending on the assigned stage.
Hmax / Mmax ratio
The Hmax / Mmax ratio serves as an objective electrophysiological index of spinal motor neuron pool excitability. Although it does not directly measure velocity-dependent mechanical resistance, this neurophysiological marker quantifies spinal hyperexcitability, thereby providing a critical adjunct to subjective clinical scales.
Measured: From enrollment to the completion of treatment, varying by stage: 1 day for Stages 1 and 3, and 2 to 4 days for Stage 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion16 Mar 2028 (estimated)
- Study completion16 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Post-Stroke SpasticityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-case experimental research
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilker şengül, Izmir Katip Celebi University
- Investigators
- İlker Şengül, M.D., Principal investigator, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617311
- Sponsor's protocol ID
- 2026-KAE-0011
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since all necessary demographic, clinical, and outcome data will be reported and published in a manuscript as per the study methodology, IPD sharing is currently not deemed required.
Publications
Love S, Gibson N, Smith N, Bear N, Blair E; Australian Cerebral Palsy Register Group. Interobserver reliability of the Australian Spasticity Assessment Scale (ASAS). Dev Med Child Neurol. 2016 Feb;58 Suppl 2:18-24. doi: 10.1111/dmcn.13000. Epub 2016 Jan 14.
PubMed 26762706Childers MK, Biswas SS, Petroski G, Merveille O. Inhibitory casting decreases a vibratory inhibition index of the H-reflex in the spastic upper limb. Arch Phys Med Rehabil. 1999 Jun;80(6):714-6. doi: 10.1016/s0003-9993(99)90178-8.
PubMed 10378501Katz RT, Rovai GP, Brait C, Rymer WZ. Objective quantification of spastic hypertonia: correlation with clinical findings. Arch Phys Med Rehabil. 1992 Apr;73(4):339-47. doi: 10.1016/0003-9993(92)90007-j.
PubMed 1554307He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.
PubMed 37475737Burke D. Clinical uses of H reflexes of upper and lower limb muscles. Clin Neurophysiol Pract. 2016 Apr 7;1:9-17. doi: 10.1016/j.cnp.2016.02.003. eCollection 2016.
PubMed 30214954Cameron T, McDonald K, Anderson L, Prochazka A. The effect of wrist angle on electrically evoked hand opening in patients with spastic hemiplegia. IEEE Trans Rehabil Eng. 1999 Mar;7(1):109-11. doi: 10.1109/86.750560.
PubMed 10188613Sentandreu-Mano T, Tomas JM, Ricardo Salom Terradez J. A randomised clinical trial comparing 35 Hz versus 50 Hz frequency stimulation effects on hand motor recovery in older adults after stroke. Sci Rep. 2021 Apr 28;11(1):9131. doi: 10.1038/s41598-021-88607-8.
PubMed 33911100Malhotra S, Rosewilliam S, Hermens H, Roffe C, Jones P, Pandyan AD. A randomized controlled trial of surface neuromuscular electrical stimulation applied early after acute stroke: effects on wrist pain, spasticity and contractures. Clin Rehabil. 2013 Jul;27(7):579-90. doi: 10.1177/0269215512464502. Epub 2012 Nov 5.
PubMed 23129814Schuhfried O, Crevenna R, Fialka-Moser V, Paternostro-Sluga T. Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. J Rehabil Med. 2012 Feb;44(2):99-105. doi: 10.2340/16501977-0941.
PubMed 22334346King TI II. The effect of neuromuscular electrical stimulation in reducing tone. Am J Occup Ther. 1996 Jan;50(1):62-4. doi: 10.5014/ajot.50.1.62. No abstract available.
PubMed 8644838Alfieri V. Electrical treatment of spasticity. Reflex tonic activity in hemiplegic patients and selected specific electrostimulation. Scand J Rehabil Med. 1982;14(4):177-82. No abstract available.
PubMed 6983718Stowe AM, Hughes-Zahner L, Barnes VK, Herbelin LL, Schindler-Ivens SM, Quaney BM. A pilot study to measure upper extremity H-reflexes following neuromuscular electrical stimulation therapy after stroke. Neurosci Lett. 2013 Feb 22;535:1-6. doi: 10.1016/j.neulet.2012.11.063. Epub 2013 Jan 8.
PubMed 23313593Stein C, Fritsch CG, Robinson C, Sbruzzi G, Plentz RD. Effects of Electrical Stimulation in Spastic Muscles After Stroke: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Stroke. 2015 Aug;46(8):2197-205. doi: 10.1161/STROKEAHA.115.009633. Epub 2015 Jul 14.
PubMed 26173724Kinnear BZ, Lannin NA, Cusick A, Harvey LA, Rawicki B. Rehabilitation therapies after botulinum toxin-A injection to manage limb spasticity: a systematic review. Phys Ther. 2014 Nov;94(11):1569-81. doi: 10.2522/ptj.20130408. Epub 2014 Jul 24.
PubMed 25060957Demetrios M, Khan F, Turner-Stokes L, Brand C, McSweeney S. Multidisciplinary rehabilitation following botulinum toxin and other focal intramuscular treatment for post-stroke spasticity. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009689. doi: 10.1002/14651858.CD009689.pub2.
PubMed 23740539
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular Electrical Stimulation on Spasticity: A Single-Subject Experimental Study
- ClinicalTrials.gov ID
- NCT07617311
- Acronym / sponsor ID
- 2026-KAE-0011
- Conditions
- Post-Stroke Spasticity
- Keywords
- Post-stroke spasticity, Neuromuscular electrical stimulation, Muscle reaction angle, H reflex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 16 Mar 2028 (estimated)
- Study completion
- 16 Mar 2028 (estimated)
- First posted
- 1 Jun 2026 (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.
The goal of this clinical trial is to learn if neuromuscular electrical stimulation (NMES) works to treat spasticity in adult patients with spasticity related to stroke. The main question it aims to answer is:
- Does NMES reduces the severity of spasticity? Researchers will compare NMES treatment to baseline and non-stimulation periods to see if NMES works to treat spasticity.
Participants will:
- first undergo an initial assessment at 10-minute intervals for one hour, followed by 20 minutes of NMES exposure, and subsequent post-treatment assessments at 10-minute intervals for two hours. This daily procedure will be repeated over four days for one patient, and performed only once for the remaining three patients.
Detailed description
Spasticity is a sensory-motor control disorder arising from upper motor neuron lesions, affecting approximately 97% of chronic stroke patients presenting with moderate-to-severe motor impairment. This pathology is driven by stretch reflex hyperexcitability, stemming from secondary alterations in the supraspinal, spinal interneuronal, and striated muscle systems; it manifests as an exaggerated reflex response to peripheral stimuli and concomitant excessive muscle activity. While several definitions exist in the literature, the operational conceptualization of spasticity as 'the enhancement of velocity-dependent stretch reflexes, measured at rest' establishes it as a highly quantifiable and robust target variable for clinical evaluation and scientific investigation.
Spasticity management encompasses diverse therapeutic modalities, ranging from pharmacological to non-pharmacological approaches. Among these, neuromuscular electrical stimulation (NMES) has emerged as a prominent intervention. Although documented as a beneficial adjunctive therapy, the clinical translation of NMES from randomized controlled trials to bedside practice is frequently hindered by marked study heterogeneity and a scarcity of high-quality evidence. Moreover, despite its clinical adoption, NMES application parameters remain largely unstandardized, and substantial inter-individual variability precludes the direct extrapolation of group-level averages to individual patients. Therefore, rigorous experimental frameworks capable of generating robust, individual-level scientific evidence are required to guide real-world practice and optimize personalized therapeutic decisions. Within this paradigm, single-subject experimental designs represent a highly promising methodological approach.
Consequently, this study investigates the therapeutic efficacy of NMES on spasticity among chronic stroke patients with spastic paresis lasting longer than one year, utilizing single-subject experimental methodologies-specifically withdrawal/reversal and multiple-baseline designs. To achieve this, this research addresses four primary objectives: evaluating whether standalone NMES reduces spasticity severity; determining the longevity of any observed therapeutic effect; quantifying the precise magnitude of this intervention; and examining the generalizability of the outcomes. Framed within the context of the experimental design-analysis paradigm, we hypothesize that isolated NMES application will significantly reduce spasticity. This hypothesis will be systematically tested across three distinct stages. The initial pilot stage will delineate the presence, magnitude, and duration of NMES efficacy using predefined stimulation parameters. Subsequently, the second stage will implement a withdrawal/reversal design with built-in wash-out periods to provide robust causal evidence regarding NMES outcomes. Finally, the third stage will deploy a multiple-baseline design across participants to establish the generalizability of the intervention parameters.
In the first stage, a basic phase-change (A-B) design will be applied to a single participant, where Phase A represents the untreated baseline period, and Phase B denotes the NMES application followed immediately by post-treatment assessments. Specifically, the participant will undergo a baseline assessment at 10-minute intervals for one hour, followed by a 20-minute NMES application, and subsequent post-treatment assessments at 10-minute intervals for two hours. This initial stage serves as a pilot phase designed to evaluate potential NMES-related effects, and progression to Stage 2 will occur independently of the treatment's efficacy status during this pilot.
In the second stage, this daily procedure is planned to be repeated over four consecutive days separated by washout intervals for the same participant, yielding a full A-B-A-B-A-B-A sequence. However, the study incorporates a strict ethical stopping rule: if visual analysis reveals no positive clinical response by the end of the second day (concluding the initial A-B-A-B phases), the protocol will be discontinued immediately due to futility, and the study will not proceed to the final stage. Conversely, if a positive response is verified visually, the full four-day sequence will be completed, and a non-concurrent multiple baseline design across participants (the final stage) will subsequently be implemented.
In the final stage, the single-day (A-B) procedure will be applied only once to three additional participants. To ensure methodological rigor, the baseline lengths for these three participants will consist of 5, 7, and 9 assessments, respectively, assigned in a randomized order.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case experimental research
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) | Experimental | Device: Neuromuscular electrical stimulation (NMES)Neuromuscular electrical stimulation (NMES) (a symmetric, biphasic, rectangular waveform) will be administered to the antagonist wrist extensors (extensor carpi radialis longus/brevis and extensor carpi ulnaris) of the spastic wrist flexors in the B (intervention) phase. The configuration consists of an application duration of 20 minutes, a stimulation frequency of 35 Hz, and a pulse duration of 300 μs. The duty cycle will feature a 20-second ON time and 20-second OFF time (1:1 ratio), with ramp-up and ramp-down durations set at 5 seconds. During Phase A, no intervention will be carried out |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years
- Post-stroke wrist flexor spasticity scored as Grade 2 or 3 on the Australian Spasticity Assessment Scale (ASAS), specifically selecting patients whose passive stretch resistance (post-catch response) can be easily overcome to ensure accurate and unconfounded electrophysiological evaluation.
- Provision of voluntary, written informed consent prior to study enrollment.
Key exclusion criteria (13 listed)
- Age <18 or >70 year
- Contraindications to neuromuscular electrical stimulation (e.g., active electronic implants, history of epilepsy, or localized skin lesions preventing electrode placement)
- Concomitant wrist contracture or pain sufficient to impede clinical evaluation
- Structural abnormalities of the elbow joint obstructing median nerve stimulation
- Median nerve neuropathy or injury in the ipsilateral upper extremity.
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 (NMES)Neuromuscular electrical stimulation (NMES) (a symmetric, biphasic, rectangular waveform) will be administered to the antagonist wrist extensors (extensor carpi radialis longus/brevis and extensor carpi ulnaris) of the spastic wrist flexors in the B phase. The configuration consists of an application duration of 20 minutes, a stimulation frequency of 35 Hz, and a pulse duration of 300 μs. The duty cycle will feature a 20-second ON time and 20-second OFF time (1:1 ratio), with ramp-up and ramp-down durations set at 5 seconds. | Device | Neuromuscular electrical stimulation (NMES) |
| Neuromuscular electrical stimulation (NMES)Neuromuscular electrical stimulation (NMES) is a therapeutic modality used in neurorehabilitation. By delivering transcutaneous electrical currents, NMES elicits repetitive, patterned muscle contractions to augment or restore motor functions. | Device | Neuromuscular electrical stimulation (NMES) |
Primary outcome
Angle of Muscle Reaction
Time frame: From enrollment up to 1 day (Stages 1 and 3) or 2 to 4 days (Stage 2), depending on the assigned stage.
The Angle of Muscle Reaction is the specific joint angle at which a catch response is elicited in the target muscles (flexor carpi radialis and flexor carpi ulnaris) during a passive stretch delivered at the highest possible velocity.
Hmax / Mmax ratio
Time frame: From enrollment to the completion of treatment, varying by stage: 1 day for Stages 1 and 3, and 2 to 4 days for Stage 2.
The Hmax / Mmax ratio serves as an objective electrophysiological index of spinal motor neuron pool excitability. Although it does not directly measure velocity-dependent mechanical resistance, this neurophysiological marker quantifies spinal hyperexcitability, thereby providing a critical adjunct to subjective clinical scales.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 26762706Love S, Gibson N, Smith N, Bear N, Blair E; Australian Cerebral Palsy Register Group. Interobserver reliability of the Australian Spasticity Assessment Scale (ASAS). Dev Med Child Neurol. 2016 Feb;58 Suppl 2:18-24. doi: 10.1111/dmcn.13000. Epub 2016 Jan 14.
- Background: PubMed 10378501Childers MK, Biswas SS, Petroski G, Merveille O. Inhibitory casting decreases a vibratory inhibition index of the H-reflex in the spastic upper limb. Arch Phys Med Rehabil. 1999 Jun;80(6):714-6. doi: 10.1016/s0003-9993(99)90178-8.
- Background: PubMed 1554307Katz RT, Rovai GP, Brait C, Rymer WZ. Objective quantification of spastic hypertonia: correlation with clinical findings. Arch Phys Med Rehabil. 1992 Apr;73(4):339-47. doi: 10.1016/0003-9993(92)90007-j.
- Background: PubMed 37475737He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.
- Background: PubMed 30214954Burke D. Clinical uses of H reflexes of upper and lower limb muscles. Clin Neurophysiol Pract. 2016 Apr 7;1:9-17. doi: 10.1016/j.cnp.2016.02.003. eCollection 2016.
- Background: PubMed 10188613Cameron T, McDonald K, Anderson L, Prochazka A. The effect of wrist angle on electrically evoked hand opening in patients with spastic hemiplegia. IEEE Trans Rehabil Eng. 1999 Mar;7(1):109-11. doi: 10.1109/86.750560.
- Background: PubMed 33911100Sentandreu-Mano T, Tomas JM, Ricardo Salom Terradez J. A randomised clinical trial comparing 35 Hz versus 50 Hz frequency stimulation effects on hand motor recovery in older adults after stroke. Sci Rep. 2021 Apr 28;11(1):9131. doi: 10.1038/s41598-021-88607-8.
- Background: PubMed 23129814Malhotra S, Rosewilliam S, Hermens H, Roffe C, Jones P, Pandyan AD. A randomized controlled trial of surface neuromuscular electrical stimulation applied early after acute stroke: effects on wrist pain, spasticity and contractures. Clin Rehabil. 2013 Jul;27(7):579-90. doi: 10.1177/0269215512464502. Epub 2012 Nov 5.
- Background: PubMed 22334346Schuhfried O, Crevenna R, Fialka-Moser V, Paternostro-Sluga T. Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. J Rehabil Med. 2012 Feb;44(2):99-105. doi: 10.2340/16501977-0941.
- Background: PubMed 8644838King TI II. The effect of neuromuscular electrical stimulation in reducing tone. Am J Occup Ther. 1996 Jan;50(1):62-4. doi: 10.5014/ajot.50.1.62. No abstract available.
- Background: PubMed 6983718Alfieri V. Electrical treatment of spasticity. Reflex tonic activity in hemiplegic patients and selected specific electrostimulation. Scand J Rehabil Med. 1982;14(4):177-82. No abstract available.
- Background: PubMed 23313593Stowe AM, Hughes-Zahner L, Barnes VK, Herbelin LL, Schindler-Ivens SM, Quaney BM. A pilot study to measure upper extremity H-reflexes following neuromuscular electrical stimulation therapy after stroke. Neurosci Lett. 2013 Feb 22;535:1-6. doi: 10.1016/j.neulet.2012.11.063. Epub 2013 Jan 8.
- Individual participant dataSharing planned: No. Since all necessary demographic, clinical, and outcome data will be reported and published in a manuscript as per the study methodology, IPD sharing is currently not deemed required.
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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.
İlker Şengül, M.D. principal investigator
İzmir Katip Çelebi University
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 (NMES) in people with Post-Stroke Spasticity, run by Izmir Katip Celebi University 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 3 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlker Şengül, M.D. (+905337333698, ilkrsngl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angle of Muscle Reaction (time frame: From enrollment up to 1 day (Stages 1 and 3) or 2 to 4 days (Stage 2), depending on the assigned stage.). 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?
On the ClinicalTrials.gov record for NCT07617311, which also lists 22 linked publications.
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 3 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.