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The purpose of this clinical trial is to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is effective in reducing spasticity in adults with post-stroke spasticity. The primary research question is whether TENS can reduce the severity of spasticity. The effectiveness of TENS will be assessed by comparing spasticity-related outcomes measured before, during, and after the intervention. Participants will first undergo a one-hour baseline monitoring period, during which assessments will be conducted at 10-minute intervals. This will be followed by a 30-minute TENS intervention and a two-hour follow-up period, with assessments performed every 10 minutes. One participant will repeat this protocol once daily for three consecutive days, whereas the remaining three participants will undergo the procedure on a single occasion.
Post-stroke spasticity is a common consequence of upper motor neuron lesions and is characterized by increased muscle overactivity and exaggerated stretch reflex responses. It can negatively affect motor function, daily activities, and quality of life in stroke survivors.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive and widely used rehabilitation modality that may modulate spinal and supraspinal neural mechanisms through activation of sensory afferent pathways. Although previous studies have reported potential benefits of TENS for spasticity management, findings remain inconsistent because of methodological heterogeneity, variability in stimulation parameters, and differences in individual treatment responses.
The purpose of this study is to evaluate the effects of sensory-level TENS on wrist flexor spasticity and spinal motor neuron excitability in individuals with chronic post-stroke spastic paresis. Specifically, the study will examine whether TENS influences clinical spasticity, the duration of any observed effects, the magnitude of treatment-related changes, and the reproducibility of these effects across participants.
Two complementary single-case experimental designs will be used. First, a withdrawal/reversal design (ABABA with washout periods) will be employed to evaluate the causal effects of TENS on outcome measures. Second, a nonconcurrent multiple-baseline design across participants will be used to assess the consistency of intervention effects across individuals.
TENS will be applied over the paretic wrist flexor muscles for 30 minutes using symmetrical biphasic rectangular pulses (100 Hz, 200 μs). Stimulation intensity will be adjusted to a clearly perceived sensory level without visible muscle contraction or discomfort.
The primary outcomes are clinical spasticity, assessed by muscle reaction angle during rapid passive stretch, and spinal motor neuron excitability, assessed by the Hmax/Mmax ratio obtained from flexor carpi radialis H-reflex recordings. Repeated measurements will be performed throughout the experimental phases to evaluate immediate and time-dependent changes associated with TENS application.
This study is expected to provide individual-level evidence regarding the effects and temporal characteristics of sensory-level TENS in chronic post-stroke spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Participants with chronic post-stroke wrist flexor spasticity will receive sensory-level transcutaneous electrical nerve stimulation (TENS) applied over the paretic wrist flexor muscles during the intervention (B) phase. TENS will be delivered for 30 minutes using a symmetrical biphasic rectangular waveform with a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to a clearly perceived sensory level without visible muscle contraction or discomfort. During the baseline (A) phase, no intervention will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Device | Transcutaneous electrical nerve stimulation (TENS) will be applied over the projection area of the paretic wrist flexor muscles (flexor carpi radialis) for 30 minutes. Stimulation parameters will consist of symmetrical biphasic rectangular pulses at a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to produce a clearly perceived sensory sensation without visible muscle contraction or discomfort. |
| Measure | Description | Time Frame |
|---|---|---|
| Angle of Muscle Reaction | The Angle of Muscle Reaction (AMR) is defined as the joint angle at which a catch response is elicited in the wrist flexor muscles (flexor carpi radialis and flexor carpi ulnaris) during passive stretch performed at the highest achievable velocity. Higher values indicate lower spasticity. | From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design). |
| Hmax / Mmax ratio | The Hmax/Mmax ratio is an electrophysiological measure of spinal motor neuron excitability obtained from flexor carpi radialis H-reflex recordings. Higher values indicate greater spinal motor neuron excitability. | From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Korhan B Bayram, M.D. | Contact | +905073066695 | korbay@gmail.com | |
| Büşra Candal, M.D. | Contact | +905436940747 | busraalpppp@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Korhan B Bayram | Izmir Katip Celebi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Katip Çelebi University | Izmir | Karabağlar | 35150 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lance JW. Symposium synopsis. In: Feldman RG, Young RR, Koella WP, editors. Spasticity: Disordered Motor Control. Chicago: Year Book Medical Publishers; 1980. p. 485-494. | ||
| 39796261 | Background | Chen B, Yang T, Liao Z, Sun F, Mei Z, Zhang W. Pathophysiology and Management Strategies for Post-Stroke Spasticity: An Update Review. Int J Mol Sci. 2025 Jan 5;26(1):406. doi: 10.3390/ijms26010406. | |
| Background | Tate RL, Perdices M. Introduction to single-case experimental designs: historical overview and basic concepts. In: Tate RL, Perdices M, editors. Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings: Planning, Conduct, Analysis and Reporting. New York: Routledge; 2019. p. 3-20. | ||
| 37475737 |
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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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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Single-case experimental research
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| Background |
| He 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. |
| 10378501 | Background | Childers 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. |
| 1554307 | Background | Katz 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. |
| 30214954 | Background | Burke 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. |
| 20927007 | Background | Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21. |
| 26762706 | Background | 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. |
| 27474366 | Background | Fernandez-Tenorio E, Serrano-Munoz D, Avendano-Coy J, Gomez-Soriano J. Transcutaneous electrical nerve stimulation for spasticity: A systematic review. Neurologia (Engl Ed). 2019 Sep;34(7):451-460. doi: 10.1016/j.nrl.2016.06.009. Epub 2016 Jul 26. English, Spanish. |
| 30452892 | Background | Mahmood A, Veluswamy SK, Hombali A, Mullick A, N M, Solomon JM. Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity in Adults With Stroke: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):751-768. doi: 10.1016/j.apmr.2018.10.016. Epub 2018 Nov 16. |
| 17964875 | Background | Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001. |
| 1373366 | Background | Levin MF, Hui-Chan CW. Relief of hemiparetic spasticity by TENS is associated with improvement in reflex and voluntary motor functions. Electroencephalogr Clin Neurophysiol. 1992 Apr;85(2):131-42. doi: 10.1016/0168-5597(92)90079-q. |
| 11918648 | Background | Lazorthes Y, Sol JC, Sallerin B, Verdie JC. The surgical management of spasticity. Eur J Neurol. 2002 May;9 Suppl 1:35-41; dicussion 53-61. doi: 10.1046/j.1468-1331.2002.0090s1035.x. |
| 23192713 | Background | McIntyre A, Lee T, Janzen S, Mays R, Mehta S, Teasell R. Systematic review of the effectiveness of pharmacological interventions in the treatment of spasticity of the hemiparetic lower extremity more than six months post stroke. Top Stroke Rehabil. 2012 Nov-Dec;19(6):479-90. doi: 10.1310/tsr1906-479. |
| 23138834 | Background | Bakheit AM. The pharmacological management of post-stroke muscle spasticity. Drugs Aging. 2012 Dec;29(12):941-7. doi: 10.1007/s40266-012-0034-z. |
| 15799140 | Background | Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available. |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |