Spasticity as Sequela of StrokeNCT06017960
Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity
A study of Spasticity as Sequela of Stroke, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Stroke is a global health problem, with an incidence in Europe of 147/100,000 people per year. It is estimated that 43% of them present spasticity throughout the first year, causing disability, hindering mobility and functionality, which can generate comorbidity problems, which in turn hinders its improvement over… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity as Sequela of Stroke
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2023to 11 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years old
- understand and voluntarily sign informed consent before performing the intervention
- have a medical diagnosis of ischemic or hemorrhagic stroke
- have a grade between 1-3 according to the modified Ashworth scale (MAS) on the triceps sural
- able to walk independently to perform gait test
Who cannot join
- recurrent stroke
- who have received previous treatments of botulinum toxin type A in the last 3 months
- who have received treatments with dry needling in the last month
- severe cognitive deficits
- fear of needles
- metal allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is a global health problem, with an incidence in Europe of 147/100,000 people per year. It is estimated that 43% of them present spasticity throughout the first year, causing disability, hindering mobility and functionality, which can generate comorbidity problems, which in turn hinders its improvement over time.
Recently, high quality studies have conclude that there is a moderate level of evidence with large effect size in reducing spasticity with dry needling, as well as being cost-effective in stroke patients in both the subacute and chronic phases. However, due to the limitation of manual evaluations of spasticity, and it is necessary to look for measurement alternatives that complement it, such as the analysis of the electromyographic activity and the muscular structure measured with ultrasound. These data could provide objective, useful and complementary information to clinical assessments to be more specific and effective in the treatment of stroke patients.
This randomized controlled trial aim to analyse the effect of dry needling in this parameters in patients with stroke and spasticity, as well as correlated with gait variables. Each participant will be randomly assigned to the dry needling group or to the sham dry needling group, where participants receive a total of 4 sessions of ultrasound-guided dry needling or sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week. Measures of spasticity, electromyographic activity and muscle structure via ultrasound will made at baseline (T0) and immediate after each intervention (T1,T2,T3,T4). Gait variables will be made at baseline and after the last intervention (T0 and T4).
Read the detailed description
The aim of the study is to analyse the effect of dry needling in stroke patients. The investigators hypothesized dry needling will decrease spasticity and electromyographic activity of spastic muscles during dynamic stretching and at rest, causing a reduction of their abnormal hyperactivity.
Secondary, dry needling will also improve the maximum muscle contraction capacity; will improve spastic muscle ultrasound variables in terms of decreased muscle thickness and pennation angle, increased fasciculus length and reduced pixel intensity measured via histogram and second order histogram parameters; as well as dry needling will improve gait parameters such as gait speed, functional gait and better spatiotemporal parameters such as a reduction of the variability, asymmetry and an improve of the stride length.
On the other hand, the investigators hypothesized that there is a correlation between the changes that will be found in the electromyographic activity, the ultrasound variables, and the clinical and gait variables. This information will allow us to make useful predictions of best responders to dry needling according to the information obtained in electromyographic and ultrasound explorations.
The study will be a randomized clinical trial with a control group. Each participant will be randomly assigned to the dry needling group or to the sham dry needling group with a 1:1 ratio, where they will receive a total of 4 sessions of ultrasound-guided dry needling or sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week.
After being informed about the study, all eligible patients give their written informed consent.
- Conditions
- Spasticity as Sequela of Stroke
- Being tested
- Dry needling + usual care, Sham dry needling + usual care
- Keywords
- Dry needling, Spasticity, Hypertonia, Surface electromyography, Diagnostic ultrasound, Gait
- Medical subject headings
- Muscle Spasticity, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling + usual careOther
Participants assigned to the dry needling group will receive a weekly session for four weeks of ultrasound-guided dry needling in the inner gastrocnemius muscle with disposable stainless-steel needles, according to the depth of the muscle to be treated. For the realization of the technique, the diagnostic criteria of the Dry Needling in Hypertonia and Spasticity technique (DNHS®) developed by Herrero et al. will be applied adapted to the characteristics of the study, as well as the procedure for its application.
The ultrasound guidance will be the same ultrasound device than in the assessments. This ultrasound-guided intervention allows to guarantee the safety of the approach, to have the certainty in the location of the target structure and to see the responses of local spasm. During the application of the technique, patient will not look at the ultrasound screen to ensure the blindness of the patient to the group allocated.
Sham dry needling + usual careOther
Participants assigned to this group will receive the same assessments, the same number of sessions, and the sham dry needling at the same site as the dry needling group, but with a sham intervention, where the needle is dropped through the guide tube and touch the skin. The patient will not feel anything, or at most that the needle touches the skin, since it does not get into the subcutaneous cell tissue, as placebo interventions were performed in similar studies. The context will be simulated in its entirety, using the same ultrasound and disposable needles for the intervention.
Both groups will continue their daily motor rehabilitation treatment during the 4 weeks, which consists of strength training, balance, motor control, gait training, and mass practice oriented to tasks of intensity and duration appropriate to each patient, allowing the fastest possible clinical improvement, as recommended by clinical practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling group | Experimental | Dry needling + usual care. Subjects will receive a total of 4 sessions of ultrasound-guided dry needling over 4 weeks, one per week. Receives: Other: Dry needling + usual care |
| Control group | Sham comparator | Sham or simulated dry needling. + usual care. Subjects will receive a total of 4 sessions of sham ultrasound-guided dry needling over 4 weeks, one per week. Receives: Other: Sham dry needling + usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
The modified Ashworth scale (MAS) will be the main outcome of the investigation, as is one of the most studied scales in the application of dry needling in patients with spasticity in stroke population. The MAS is indicated to assess spasticity, or positive speed-dependent stretching reflex, in pathologies of the central nervous system.
The scale rate muscle tone on a scale between 0 and 4. 0 is no increase in tone, 1 slight increase in tone and catch/release at end of Range Of Motion (ROM), 1+ with catch/release through 1/2 ROM, 2 more marked increased in tone through ROM, but affected part moved easily, 3 considerable increase in tone, passive movement difficult, 4 affected part rigid flexion or extension.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
Secondary outcomes (18)
surface Electromyography (sEMG) - Activity at rest
The first test will evaluate the muscle activity at rest, while the subject is asked to be relaxed, the Root Mean Square (RMS) of both inner gastrocnemius will be measured for 30 seconds.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
sEMG - Dynamic stretching
The second measurement will consist of a dynamic stretch to assess muscular activity during the speed-dependent stretching reflex or spasticity. For this, 10 passive stretches will be performed according to the method described and validated by Marinelli et al. 2013, that showed an easily reproducible constant speed and rhythm to avoid intra-rater bias along the study.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
sEMG - Maximum Voluntary Isometric Contraction
The third test will consist of evaluating the Maximum Voluntary Isometric Contraction (MVIC) of the internal gastrocnemius muscle. To do this, the ankle will be placed in an intermediate position, with neither fully elongated nor fully shortened muscle fibers, and 5 seconds of maximum isometric contraction towards plantar flexion will be performed 3 times, leaving an interval of 60 seconds between repetitions. Then the maximum values of electromyographic activation of each repetition will be selected to obtain the mean value.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
Ultrasound (US) - Muscle thickness
Muscle thickness is the distance between deep and superficial aponeurosis of a muscle, from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Pennation angle
The pennation angle is defined as the angle formed by the muscle fasciculus with the deep aponeurosis, from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Fascicle length
Fascicle length is the length of the fascicular path between the insertions of the fascicle into the superficial and deep aponeuroses, from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Histogram/Echo intensity
Echo intensity was defined as the brightness of the image acquired through ultrasound. It is expressed in gray scale between 0 and 255 after processing the image in an image analysis software, from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Grey level co-occurrence matrices (GLCM)
Grey level co-occurrence matrices (GLCM) consist of comparing pair of pixels separated by a certain distance (by default a value of 1 is used) and in an angular direction (0°, 45°, 90°, and 135°) along the entire matrix, calculating the frequency with which certain grey levels appear in the image and their relationship with each other, from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Run-length matrices (GLRLM)
Run-length matrices (GLRLM) represents a set of consecutive pixels having the same grey level in each of the four angular directions described across the entire matrix, from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Local binary pattern (LBP)
Local binary pattern (LBP) analysis compares the intensity of a central pixel, which is taken as a reference value, with the surrounding pixels, from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Blob analysis (BA)
Blob analysis is based on detecting areas close to each other with a similar eco-intensity called "blobs", from an image of the gastrocnemius medialis obtained with ultrasound.
Measured: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
Timed Up and Go (TUG)
The Timed Up and Go (TUG) test to assess functional gait, which consists of measuring the seconds it takes the individual to get up from a chair approximately 46 centimeters high, travel 3 meters, turn and sit again. This scale has showed excellent intrarater reliability (ICC>0.95) in patients with stroke.
Measured: Baseline (T0) and after the fourth intervention in fourth week (T4).
10 Meter Walking Test (10MWT)
The 10 Meter Walking Test (10MWT) to assess the comfortable and fast speed of the march, which consists of measuring the seconds that the subject takes to travel 10 meters in a straight line to obtain the comfortable and fast speed in meters per second (m/s), with excellent intrarater reliability (ICC=0.87-0.88).
Measured: Baseline (T0) and after the fourth intervention in fourth week (T4).
6 Minute Walking Test (6MWT)
The 6 Minute Walking Test (6MWT) to assess the resistance and distance in meters that the subject travels for 6 minutes, showing good intrarater reliability (ICC=0.74), in patients with stroke.
Measured: Baseline (T0) and after the fourth intervention in fourth week (T4).
Gait variability
The variability represents the coefficient of variation of cycle duration in percent (%) measured with a validated tool for spatiotemporal gait analysis
Measured: Baseline (T0) and after the fourth intervention in fourth week (T4).
Gait asymmetry
The asymmetry is the ratio of swing times, which compares the time in the air of each foot in percent (%) measured with a validated tool for spatiotemporal gait analysis.
Measured: Baseline (T0) and after the fourth intervention in fourth week (T4).
Affected leg stride length
The stride length describes the distance between two successive footprints on the ground, from the heel of a foot to the heel on the same foot, one cycle after, measured with a validated tool for spatiotemporal gait analysis. Both affected and non affected leg stride length will be measured.
Measured: Baseline (T0) and after the fourth intervention in fourth week (T4).
Non-affected leg stride length
The stride length describes the distance between two successive footprints on the ground, from the heel of a foot to the heel on the same foot, one cycle after, measured with a validated tool for spatiotemporal gait analysis. Both affected and non affected leg stride length will be measured.
Measured: Baseline (T0) and after the fourth intervention in fourth week (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start15 Sep 2023
- Primary completion11 Aug 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Spasticity as Sequela of 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
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala
- Responsible party
- Principal investigator, Dr. Pablo Herrero Gallego, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017960
- Sponsor's protocol ID
- EMGUS-DN
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diaz-Guzman J, Egido JA, Gabriel-Sanchez R, Barbera-Comes G, Fuentes-Gimeno B, Fernandez-Perez C; IBERICTUS Study Investigators of the Stroke Project of the Spanish Cerebrovascular Diseases Study Group. Stroke and transient ischemic attack incidence rate in Spain: the IBERICTUS study. Cerebrovasc Dis. 2012;34(4):272-81. doi: 10.1159/000342652. Epub 2012 Oct 20.
PubMed 23095851Dornak T, Justanova M, Konvalinkova R, Riha M, Muzik J, Hoskovcova M, Srp M, Navratilova D, Otruba P, Gal O, Svobodova I, Dusek L, Bares M, Kanovsky P, Jech R. Prevalence and evolution of spasticity in patients suffering from first-ever stroke with carotid origin: a prospective, longitudinal study. Eur J Neurol. 2019 Jun;26(6):880-886. doi: 10.1111/ene.13902. Epub 2019 Feb 8.
PubMed 30623522Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
PubMed 14684785Simic-Panic D, Boskovic K, Milicevic M, Rabi Zikic T, Cvjetkovic Bosnjak M, Tomasevic-Todorovic S, Jovicevic M. The Impact of Comorbidity on Rehabilitation Outcome after Ischemic Stroke. Acta Clin Croat. 2018 Mar;57(1):5-15. doi: 10.20471/acc.2018.57.01.01.
PubMed 30256006Kabboord AD, Van Eijk M, Buijck BI, Koopmans RTCM, van Balen R, Achterberg WP. Comorbidity and intercurrent diseases in geriatric stroke rehabilitation: a multicentre observational study in skilled nursing facilities. Eur Geriatr Med. 2018;9(3):347-353. doi: 10.1007/s41999-018-0043-5. Epub 2018 Mar 13.
PubMed 29887923Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.
PubMed 33978513Puce L, Curra A, Marinelli L, Mori L, Capello E, Di Giovanni R, Bodrero M, Solaro C, Cotellessa F, Fattapposta F, Trompetto C. Spasticity, spastic dystonia, and static stretch reflex in hypertonic muscles of patients with multiple sclerosis. Clin Neurophysiol Pract. 2021 Jun 16;6:194-202. doi: 10.1016/j.cnp.2021.05.002. eCollection 2021.
PubMed 34278056Marinelli L, Trompetto C, Mori L, Vigo G, Traverso E, Colombano F, Abbruzzese G. Manual linear movements to assess spasticity in a clinical setting. PLoS One. 2013;8(1):e53627. doi: 10.1371/journal.pone.0053627. Epub 2013 Jan 15.
PubMed 23335966Bynum R, Garcia O, Herbst E, Kossa M, Liou K, Cowan A, Hilton C. Effects of Dry Needling on Spasticity and Range of Motion: A Systematic Review. Am J Occup Ther. 2021 Jan-Feb;75(1):7501205030p1-7501205030p13. doi: 10.5014/ajot.2021.041798.
PubMed 33399051Fernandez Sanchis D, Cuenca Zaldivar JN, Calvo S, Herrero P, Gomez Barrera M. Cost-effectiveness of upper extremity dry needling in the rehabilitation of patients with stroke. Acupunct Med. 2022 Apr;40(2):160-168. doi: 10.1177/09645284211055750. Epub 2021 Dec 2.
PubMed 34856821Fernandez-Sanchis D, Brandin-de la Cruz N, Jimenez-Sanchez C, Gil-Calvo M, Herrero P, Calvo S. Cost-Effectiveness of Upper Extremity Dry Needling in Chronic Stroke. Healthcare (Basel). 2022 Jan 14;10(1):160. doi: 10.3390/healthcare10010160.
PubMed 35052323Yu B, Zhang X, Cheng Y, Liu L, YanJiang, Wang J, Lu X. The Effects of the Biceps Brachii and Brachioradialis on Elbow Flexor Muscle Strength and Spasticity in Stroke Patients. Neural Plast. 2022 Mar 2;2022:1295908. doi: 10.1155/2022/1295908. eCollection 2022.
PubMed 35283993Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245Campanella W, Corazza A, Puce L, Privitera L, Pedrini R, Mori L, Boccuni L, Turtulici G, Trompetto C, Marinelli L. Shear wave elastography combined with electromyography to assess the effect of botulinum toxin on spastic dystonia following stroke: A pilot study. Front Neurol. 2022 Oct 10;13:980746. doi: 10.3389/fneur.2022.980746. eCollection 2022.
PubMed 36299267Collen FM, Wade DT, Bradshaw CM. Mobility after stroke: reliability of measures of impairment and disability. Int Disabil Stud. 1990 Jan-Mar;12(1):6-9. doi: 10.3109/03790799009166594.
PubMed 2211468
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity
- ClinicalTrials.gov ID
- NCT06017960
- Acronym / sponsor ID
- EMGUS-DN
- Conditions
- Spasticity as Sequela of Stroke
- Keywords
- Dry needling, Spasticity, Hypertonia, Surface electromyography, Diagnostic ultrasound, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- University of Alcala
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 11 Aug 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 30 Aug 2023 (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 global health problem, with an incidence in Europe of 147/100,000 people per year. It is estimated that 43% of them present spasticity throughout the first year, causing disability, hindering mobility and functionality, which can generate comorbidity problems, which in turn hinders its improvement over time.
Recently, high quality studies have conclude that there is a moderate level of evidence with large effect size in reducing spasticity with dry needling, as well as being cost-effective in stroke patients in both the subacute and chronic phases. However, due to the limitation of manual evaluations of spasticity, and it is necessary to look for measurement alternatives that complement it, such as the analysis of the electromyographic activity and the muscular structure measured with ultrasound. These data could provide objective, useful and complementary information to clinical assessments to be more specific and effective in the treatment of stroke patients.
This randomized controlled trial aim to analyse the effect of dry needling in this parameters in patients with stroke and spasticity, as well as correlated with gait variables. Each participant will be randomly assigned to the dry needling group or to the sham dry needling group, where participants receive a total of 4 sessions of ultrasound-guided dry needling or sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week. Measures of spasticity, electromyographic activity and muscle structure via ultrasound will made at baseline (T0) and immediate after each intervention (T1,T2,T3,T4). Gait variables will be made at baseline and after the last intervention (T0 and T4).
Detailed description
The aim of the study is to analyse the effect of dry needling in stroke patients. The investigators hypothesized dry needling will decrease spasticity and electromyographic activity of spastic muscles during dynamic stretching and at rest, causing a reduction of their abnormal hyperactivity.
Secondary, dry needling will also improve the maximum muscle contraction capacity; will improve spastic muscle ultrasound variables in terms of decreased muscle thickness and pennation angle, increased fasciculus length and reduced pixel intensity measured via histogram and second order histogram parameters; as well as dry needling will improve gait parameters such as gait speed, functional gait and better spatiotemporal parameters such as a reduction of the variability, asymmetry and an improve of the stride length.
On the other hand, the investigators hypothesized that there is a correlation between the changes that will be found in the electromyographic activity, the ultrasound variables, and the clinical and gait variables. This information will allow us to make useful predictions of best responders to dry needling according to the information obtained in electromyographic and ultrasound explorations.
The study will be a randomized clinical trial with a control group. Each participant will be randomly assigned to the dry needling group or to the sham dry needling group with a 1:1 ratio, where they will receive a total of 4 sessions of ultrasound-guided dry needling or sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week.
After being informed about the study, all eligible patients give their written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dry needling group | Experimental | Other: Dry needling + usual careDry needling + usual care. Subjects will receive a total of 4 sessions of ultrasound-guided dry needling over 4 weeks, one per week. |
| Control group | Sham comparator | Other: Sham dry needling + usual careSham or simulated dry needling. + usual care. Subjects will receive a total of 4 sessions of sham ultrasound-guided dry needling over 4 weeks, one per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be over 18 years old
- understand and voluntarily sign informed consent before performing the intervention
- have a medical diagnosis of ischemic or hemorrhagic stroke
- have a grade between 1-3 according to the modified Ashworth scale (MAS) on the triceps sural
- able to walk independently to perform gait test
Key exclusion criteria (6 listed)
- recurrent stroke
- who have received previous treatments of botulinum toxin type A in the last 3 months
- who have received treatments with dry needling in the last month
- severe cognitive deficits
- fear of needles
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 |
|---|---|---|
| Dry needling + usual careParticipants assigned to the dry needling group will receive a weekly session for four weeks of ultrasound-guided dry needling in the inner gastrocnemius muscle with disposable stainless-steel needles, according to the depth of the muscle to be treated. For the realization of the technique, the diagnostic criteria of the Dry Needling in Hypertonia and Spasticity technique (DNHS®) developed by Herrero et al. will be applied adapted to the characteristics of the study, as well as the procedure for its application. The ultrasound guidance will be the same ultrasound device than in the assessments. This ultrasound-guided intervention allows to guarantee the safety of the approach, to have the certainty in the location of the target structure and to see the responses of local spasm. During the application of the technique, patient will not look at the ultrasound screen to ensure the blindness of the patient to the group allocated. | Other | Dry needling group |
| Sham dry needling + usual careParticipants assigned to this group will receive the same assessments, the same number of sessions, and the sham dry needling at the same site as the dry needling group, but with a sham intervention, where the needle is dropped through the guide tube and touch the skin. The patient will not feel anything, or at most that the needle touches the skin, since it does not get into the subcutaneous cell tissue, as placebo interventions were performed in similar studies. The context will be simulated in its entirety, using the same ultrasound and disposable needles for the intervention. Both groups will continue their daily motor rehabilitation treatment during the 4 weeks, which consists of strength training, balance, motor control, gait training, and mass practice oriented to tasks of intensity and duration appropriate to each patient, allowing the fastest possible clinical improvement, as recommended by clinical practice guidelines. | Other | Control group |
Primary outcome
Modified Ashworth Scale
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
The modified Ashworth scale (MAS) will be the main outcome of the investigation, as is one of the most studied scales in the application of dry needling in patients with spasticity in stroke population. The MAS is indicated to assess spasticity, or positive speed-dependent stretching reflex, in pathologies of the central nervous system. The scale rate muscle tone on a scale between 0 and 4. 0 is no increase in tone, 1 slight increase in tone and catch/release at end of Range Of Motion (ROM), 1+ with catch/release through 1/2 ROM, 2 more marked increased in tone through ROM, but affected part moved easily, 3 considerable increase in tone, passive movement difficult, 4 affected part rigid flexion or extension.
18 secondary outcomes
surface Electromyography (sEMG) - Activity at rest
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
sEMG - Dynamic stretching
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
sEMG - Maximum Voluntary Isometric Contraction
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
Ultrasound (US) - Muscle thickness
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Pennation angle
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Fascicle length
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Histogram/Echo intensity
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Grey level co-occurrence matrices (GLCM)
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Run-length matrices (GLRLM)
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Local binary pattern (LBP)
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
US - Blob analysis (BA)
Time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
Timed Up and Go (TUG)
Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
10 Meter Walking Test (10MWT)
Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
6 Minute Walking Test (6MWT)
Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
Gait variability
Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
Gait asymmetry
Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
Affected leg stride length
Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
Non-affected leg stride length
Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
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 14 Sep 2026.
- Background: PubMed 23095851Diaz-Guzman J, Egido JA, Gabriel-Sanchez R, Barbera-Comes G, Fuentes-Gimeno B, Fernandez-Perez C; IBERICTUS Study Investigators of the Stroke Project of the Spanish Cerebrovascular Diseases Study Group. Stroke and transient ischemic attack incidence rate in Spain: the IBERICTUS study. Cerebrovasc Dis. 2012;34(4):272-81. doi: 10.1159/000342652. Epub 2012 Oct 20.
- Background: PubMed 30623522Dornak T, Justanova M, Konvalinkova R, Riha M, Muzik J, Hoskovcova M, Srp M, Navratilova D, Otruba P, Gal O, Svobodova I, Dusek L, Bares M, Kanovsky P, Jech R. Prevalence and evolution of spasticity in patients suffering from first-ever stroke with carotid origin: a prospective, longitudinal study. Eur J Neurol. 2019 Jun;26(6):880-886. doi: 10.1111/ene.13902. Epub 2019 Feb 8.
- Background: PubMed 14684785Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
- Background: PubMed 30256006Simic-Panic D, Boskovic K, Milicevic M, Rabi Zikic T, Cvjetkovic Bosnjak M, Tomasevic-Todorovic S, Jovicevic M. The Impact of Comorbidity on Rehabilitation Outcome after Ischemic Stroke. Acta Clin Croat. 2018 Mar;57(1):5-15. doi: 10.20471/acc.2018.57.01.01.
- Background: PubMed 29887923Kabboord AD, Van Eijk M, Buijck BI, Koopmans RTCM, van Balen R, Achterberg WP. Comorbidity and intercurrent diseases in geriatric stroke rehabilitation: a multicentre observational study in skilled nursing facilities. Eur Geriatr Med. 2018;9(3):347-353. doi: 10.1007/s41999-018-0043-5. Epub 2018 Mar 13.
- Background: PubMed 33978513Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.
- Background: PubMed 34278056Puce L, Curra A, Marinelli L, Mori L, Capello E, Di Giovanni R, Bodrero M, Solaro C, Cotellessa F, Fattapposta F, Trompetto C. Spasticity, spastic dystonia, and static stretch reflex in hypertonic muscles of patients with multiple sclerosis. Clin Neurophysiol Pract. 2021 Jun 16;6:194-202. doi: 10.1016/j.cnp.2021.05.002. eCollection 2021.
- Background: PubMed 23335966Marinelli L, Trompetto C, Mori L, Vigo G, Traverso E, Colombano F, Abbruzzese G. Manual linear movements to assess spasticity in a clinical setting. PLoS One. 2013;8(1):e53627. doi: 10.1371/journal.pone.0053627. Epub 2013 Jan 15.
- Background: PubMed 33399051Bynum R, Garcia O, Herbst E, Kossa M, Liou K, Cowan A, Hilton C. Effects of Dry Needling on Spasticity and Range of Motion: A Systematic Review. Am J Occup Ther. 2021 Jan-Feb;75(1):7501205030p1-7501205030p13. doi: 10.5014/ajot.2021.041798.
- Background: PubMed 34856821Fernandez Sanchis D, Cuenca Zaldivar JN, Calvo S, Herrero P, Gomez Barrera M. Cost-effectiveness of upper extremity dry needling in the rehabilitation of patients with stroke. Acupunct Med. 2022 Apr;40(2):160-168. doi: 10.1177/09645284211055750. Epub 2021 Dec 2.
- Background: PubMed 35052323Fernandez-Sanchis D, Brandin-de la Cruz N, Jimenez-Sanchez C, Gil-Calvo M, Herrero P, Calvo S. Cost-Effectiveness of Upper Extremity Dry Needling in Chronic Stroke. Healthcare (Basel). 2022 Jan 14;10(1):160. doi: 10.3390/healthcare10010160.
- Background: PubMed 35283993Yu B, Zhang X, Cheng Y, Liu L, YanJiang, Wang J, Lu X. The Effects of the Biceps Brachii and Brachioradialis on Elbow Flexor Muscle Strength and Spasticity in Stroke Patients. Neural Plast. 2022 Mar 2;2022:1295908. doi: 10.1155/2022/1295908. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Spasticity as Sequela of Stroke
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Recruiting
Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System
Spasticity as Sequela of Stroke
Not yet recruitingPhase 4
Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
Spasticity as Sequela of Stroke
Not yet recruiting
Improving STEP in Stroke Patients
Stroke, Hemiplegia Following Ischemic Stroke
Recruiting
Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
Spasticity as Sequela of Stroke, Spastic Cerebral Palsy
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 of Spasticity as Sequela of Stroke, run by Universidad de Zaragoza 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 5 inclusion and 6 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 14 Sep 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 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. 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 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?
Modified Ashworth Scale (time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).). 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 NCT06017960, which also lists 28 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 14 Sep 2026.