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Muscle SpasticityNCT07124806

Comparison of Two Botox Injection Techniques to Improve Gait

A study testing Botulinum toxin guided by ultrasonography and anatomical references and Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography in people with Muscle Spasticity and Stroke Sequelae, run by Universidad de los Andes, Chile at 2 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

According to our hypothesis, the use of HD-EMG shall allow an accurate localization of the innervations zones of the muscles, offering a better complement to the methodology applied so far to define the botulinum neurotoxin (BoNT) injection site. Read more about this study

Who is it for?
Any age
What is being tested?
Botulinum toxin guided by ultrasonography and anatomical references and Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesChile
Study dates
1 Jul 2022to 4 Dec 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Hemiplegia secondary to an ischemic of hemorrhagic stroke.
  • Focal spasticity of gastrocnemius muscles status 1-3 according to the modified Ashworth scale.
  • Independent gait ability with or without the use of technical assistance.

Who cannot join

  • Spasticity status 4 according to the modified Ashworth scale.
  • Focal spasticity of the tibialis posterior and/or soleus.
  • Fracture and/or contracture in the lower extremities.
  • Other medical treatment for spasticity.
  • Allergy to the botulinum neurotoxin.
  • Suffering from some infectious disease
  • Pregnancy or breastfeeding

Trial locations and contacts

2 sites in 1 country.

Chile2 sites

  • Universidad de los Andes

    Santiago, Las Condes, 7620001

  • Instituto Nacional de Rehabilitación Pedro Aguirre Cerda

    Santiago, Peñalolen, 7910250

Other trials in Chile

About this study

Official title: Comparison of Effectiveness of Two Techniques to Guide the Injection of Botulinum Toxin to Improve Gait in Post-stroke Patients: Randomized Clinical Trial

According to our hypothesis, the use of HD-EMG shall allow an accurate localization of the innervations zones of the muscles, offering a better complement to the methodology applied so far to define the botulinum neurotoxin (BoNT) injection site. To achieve that goal, a randomized clinical trial comparing the effectiveness of two guiding methods to define the BoNT injection site in the gastrocnemius muscles will be conducted. One arm will be guided with ultrasonography + localized IZ using anatomical references; while the second arm with ultrasonography + in vivo location of the IZ through HD-EMG. The effectiveness will be evaluated by changes in functional tests and in biomechanical parameters of the gait assessed with a three-dimensional motion analysis system. These outcomes will be measured at baseline (T0), at three (T3w) and six weeks (T6w), post BoNT injection. The differences between sessions will be evaluated as measurements of effectiveness. We expect that greater effectiveness will be found in the group that receives the injection of BoNT, guided by the in vivo location of the IZ.

Read the detailed description

This research proposal seeks to improve the current procedures to determinate the botulinum neurotoxin (BoNT) injection site. More precisely, we propose to complement the ultrasonography with an in vivo location of the IZ, using a non-invasive technique based on surface multielectrode electromyography grid, which is called high density-surface EMG (HD-EMG). According to our hypothesis, the use of HD-EMG shall allow an accurate localization of the IZs of the muscles, offering a better complement to the methodology applied so far to define the BoNT injection site. To achieve that goal, a randomized clinical trial comparing the effectiveness of two guiding methods to define the BoNT injection site in the gastrocnemius muscles (main ankle extensors or plantar flexors) will be conducted. One arm will be treated with the best available option, which includes ultrasonography + localized IZ using anatomical references. The second arm will be managed using ultrasonography + in vivo location of the IZ through. The last will be measured using HD-EMG by recording the motor unit action potentials along the muscle fibers. This technique can identify the location of the IZ by the change of phase of those potentials. The effectiveness will be evaluated by changes in biomechanical parameters of the gait, assessed using a three-dimensional motion analysis system. The outcomes will be biomechanical gait variables associated with the ankle joint (ankle joint moment, dorsiflexion range, among others) and functional tests (spasticity using Ashworth scale, 6-minute walk test and the Timed Up and Go Test). These outcomes will be evaluated at baseline (T0), at three (T3w) and six weeks (T6w), post BoNT injection. The differences between sessions will be evaluated as measurements of effectiveness (Delta1 = T3w-T0; Delta2 = T6w - T0). To compare the effectiveness between groups, these delta values will be compared using a student's t-test or a Mann-Whitney U test, as appropriate. Also, a Cohen's d will be calculated to determine the magnitude of these differences. In addition, the post-hoc power (1-β) will be measured. All statistical analyses will be performed in the STATA software (version 14.0 Stata-Corp LP, USA), considering a one tailed analysis, and a confidence level of 95%. Statistically significant differences will be considered those associated with a p-value lower than 0.05. We expect to find greater effectiveness in the group that receives the injection of BoNT, guided by the in vivo location of the IZ using HD-EMG.

Being tested
Botulinum toxin guided by ultrasonography and anatomical references, Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography
Keywords
Post-Stroke, Gait analysis, Botulinum toxin, High-density electromyography
Medical subject headings
Muscle Spasticity, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin guided by ultrasonography and anatomical referencesCombination product

    Also called Botox injection

    The botulinum neurotoxin (BoNT) will be calculated according to the weight of each patient. It will be injected in four places: two of them into the medial gastrocnemius and the other two into the lateral gastrocnemius. For medial gastrocnemius muscle, ¼ of the dose will be injected into the muscle belly at the 25% of the distance between the popliteal fossa and the intermalleolar line. Another ¼ will be injected into the muscle belly at the 35% of the previously mentioned distance. For lateral gastrocnemius, ¼ of the dose will be injected into the muscle belly at the 20% of the distance between the popliteal fossa and the intermalleolar line. The remaining ¼ of the dose will be injected into the muscle belly at the 30% of the previously described distance. All patients will conduct the same physical therapy program and under the direction of the same team of physical therapists. This program will begin two weeks after receiving the BoNT injection.

  • Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyographyCombination product

    Also called Botox injection, Linear electrode array electromyography

    The botulinum neurotoxin (BoNT) will be calculated according to the weight of each patient. It will be injected in eight places: four will be located in vivo for gastrocnemius medialis and four for gastrocnemius lateralis. These places will correspond to innervation zones located by high-density electromyography in different zones of each muscle. Thus, each of the eight located innervation zones will receive 1/8 of the calculated dose for the gastrocnemius muscle. All patients will conduct the same physical therapy program and under the direction of the same team of physical therapists. This program will begin two weeks after receiving the BoNT injection.

Study groups in NCT07124806
Study groupRoleWhat they receive
Botulinum neurotoxin guided by ultrasonography and anatomical referencesActive comparatorPatients will be treated with a botulinum neurotoxin (BoNT) injection into the medial and lateral gastrocnemius muscles of the paretic hemi-body. This injection will be guided by ultrasonography and anatomical references described in the EUROMUSCULUS/USPRM guideline.
Receives: Combination Product: Botulinum toxin guided by ultrasonography and anatomical references
Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zoneExperimentalPatients will be treated with a botulinum neurotoxin (BoNT) injection into the medial and lateral gastrocnemius muscles of the paretic hemi-body. However, in this case the injection will be guided by ultrasonography and the in vivo location of the innervation zones using noninvasive multielectrode electromyography.
Receives: Combination Product: Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum ankle dorsiflexion during the stance phase in the paretic limb.

    Peak dorsiflexion angle during the stance phase in the paretic limb. This value will be calculated from Vicon Nexus 2.12 software, using the conventional gait model + functional calibration, and will be considered as the average value within 8 to 10 gait cycles.

    Measured: Before intervention (T0), three weeks (T3w) and six weeks (T6w) post botulinum neurotoxin injection

  2. Maximum ankle plantarflexion moment during the stance phase in the paretic limb

    Peak internal ankle dorsiflexion moment during the stance phase in the paretic limb. This value will be calculated from Vicon Nexus 2.12 software, using the conventional gait model + functional calibration, and will be considered as the average value within 8 to 10 gait cycles.

    Measured: Before intervention (T0), three weeks (T3w) and six weeks (T6w) post botulinum neurotoxin injection.

  3. Foot clearance in the paretic limb.

    Minimum distance between the lowest point on the shoe and the ground during the swing phase in the paretic limb. This value will be calculated from a custom-made biomechanical model, and will be considered as the average value within 8 to 10 gait cycles.

    Measured: Before intervention (T0), three weeks (T3w) and six weeks (T6w) post botulinum neurotoxin injection.

Secondary outcomes (3)

  1. Spasticity of plantar flexor muscles using the Ashworth modified scale.

    Qualitative evaluation of the increase in ankle plantar flexors tone during a muscle stretch movement (dorsiflexion). This will be scaled from 0 (no increase in muscle tone) to 4 (ankle rigid during dorsiflexion movement).

    Measured: Before intervention (T0), three weeks (T3w) and six weeks (T6w) post botulinum neurotoxin injection.

  2. 6-minute walk distance.

    Measurement of distance walked over a span of 6 minutes.

    Measured: Before intervention (T0), three weeks (T3w) and six weeks (T6w) post botulinum neurotoxin injection.

  3. Timed up and go time.

    Time to complete a standing from a chair with no arms, walking 5 meters and returning to sit down.

    Measured: Before intervention (T0), three weeks (T3w) and six weeks (T6w) post botulinum neurotoxin injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start1 Jul 2022
  3. Primary completion29 Nov 2022
  4. Study completion4 Dec 2022

Resources

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
The design is a randomized controlled trial. One arm will be treated with a botulinum neurotoxin (BoTN) injection guided by the best available option, including ultrasonography + localized innervation zone (IZ) using anatomical references. The second arm will be treated with BoTN but guided with ultrasonography + in vivo location of the IZ using high-density electromyography.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07124806
Sponsor's protocol ID
UAndes
Status last verified
Aug 2025
First submitted
8 Aug 2025
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol and statistical analysis plan will be published. Statistical analysis plan includes all databases used in the study. These databases will not include personal information of patients.

Publications

  • Grysiewicz RA, Thomas K, Pandey DK. Epidemiology of ischemic and hemorrhagic stroke: incidence, prevalence, mortality, and risk factors. Neurol Clin. 2008 Nov;26(4):871-95, vii. doi: 10.1016/j.ncl.2008.07.003.

    PubMed 19026895

  • Lavados PM, Sacks C, Prina L, Escobar A, Tossi C, Araya F, Feuerhake W, Galvez M, Salinas R, Alvarez G. Incidence, 30-day case-fatality rate, and prognosis of stroke in Iquique, Chile: a 2-year community-based prospective study (PISCIS project). Lancet. 2005 Jun 25-Jul 1;365(9478):2206-15. doi: 10.1016/S0140-6736(05)66779-7.

    PubMed 15978929

  • Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002 Aug;16(5):515-22. doi: 10.1191/0269215502cr512oa.

    PubMed 12194622

  • von Schroeder HP, Coutts RD, Lyden PD, Billings E Jr, Nickel VL. Gait parameters following stroke: a practical assessment. J Rehabil Res Dev. 1995 Feb;32(1):25-31.

    PubMed 7760264

  • Dashtipour K, Chen JJ, Walker HW, Lee MY. Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity. Medicine (Baltimore). 2016 Jan;95(2):e2468. doi: 10.1097/MD.0000000000002468.

    PubMed 26765447

  • Wei TS, Liu PT, Chang LW, Liu SY. Gait asymmetry, ankle spasticity, and depression as independent predictors of falls in ambulatory stroke patients. PLoS One. 2017 May 23;12(5):e0177136. doi: 10.1371/journal.pone.0177136. eCollection 2017.

    PubMed 28542281

  • Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.

    PubMed 7192811

  • Schroder AS, Fietzek UM, Pavicic T, Stehr M, Baumann AC, Ruzicka T, Heinen F. [Botulinum toxin--the all-rounder in medicine]. MMW Fortschr Med. 2011 Jan 27;153(4):33-9; quiz 40. doi: 10.1007/BF03367697. No abstract available. German.

    PubMed 22165615

  • Woolley SM. Characteristics of gait in hemiplegia. Top Stroke Rehabil. 2001 Winter;7(4):1-18. doi: 10.1310/JB16-V04F-JAL5-H1UV.

    PubMed 14523755

  • Cofre Lizama LE, Khan F, Galea MP. Beyond speed: Gait changes after botulinum toxin injections in chronic stroke survivors (a systematic review). Gait Posture. 2019 May;70:389-396. doi: 10.1016/j.gaitpost.2019.03.035. Epub 2019 Apr 4.

    PubMed 30974394

  • Karadag-Saygi E, Cubukcu-Aydoseli K, Kablan N, Ofluoglu D. The role of kinesiotaping combined with botulinum toxin to reduce plantar flexors spasticity after stroke. Top Stroke Rehabil. 2010 Jul-Aug;17(4):318-22. doi: 10.1310/tsr1704-318.

    PubMed 20826420

  • Hesse S, Krajnik J, Luecke D, Jahnke MT, Gregoric M, Mauritz KH. Ankle muscle activity before and after botulinum toxin therapy for lower limb extensor spasticity in chronic hemiparetic patients. Stroke. 1996 Mar;27(3):455-60. doi: 10.1161/01.str.27.3.455.

    PubMed 8610313

  • Pradon D, Hutin E, Khadir S, Taiar R, Genet F, Roche N. A pilot study to investigate the combined use of Botulinum toxin type-a and ankle foot orthosis for the treatment of spastic foot in chronic hemiplegic patients. Clin Biomech (Bristol). 2011 Oct;26(8):867-72. doi: 10.1016/j.clinbiomech.2011.04.003. Epub 2011 May 17.

    PubMed 21592635

  • Castelao M, Marques RE, Duarte GS, Rodrigues FB, Ferreira J, Sampaio C, Moore AP, Costa J. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev. 2017 Dec 12;12(12):CD003633. doi: 10.1002/14651858.CD003633.pub3.

    PubMed 29230798

  • Borodic G. Therapeutic botulinum toxin. Lancet. 1994 Nov 12;344(8933):1370. doi: 10.1016/s0140-6736(94)90732-3. No abstract available.

    PubMed 7968058

Questions about this trial

What is this clinical trial studying?

A study testing Botulinum toxin guided by ultrasonography and anatomical references and Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography in people with Muscle Spasticity and Stroke Sequelae, run by Universidad de los Andes, Chile at 2 sites in Chile.

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 7 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 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. 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?

Maximum ankle dorsiflexion during the stance phase in the paretic limb. (time frame: Before intervention (T0), three weeks (T3w) and six weeks (T6w) post botulinum neurotoxin injection). The study lists 3 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 NCT07124806, which also lists 71 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 15 Aug 2025.

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