Comparison of Two Botox Injection Techniques to Improve Gait

NCT07124806 | Completed DMC

• 1 other identifier: UAndes
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Muscle Spasticity; Stroke Sequelae; Spasticity as Sequela of Stroke; Gait Disorders, Neurologic

Keywords

Post-Stroke; Gait analysis; Botulinum toxin; High-density electromyography

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (3)

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

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

• 6-minute walk distance.

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

• Timed up and go time.

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

Study Arms (2)

Botulinum neurotoxin guided by ultrasonography and anatomical references

ACTIVE COMPARATOR

Patients 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.

Combination Product: Botulinum toxin guided by ultrasonography and anatomical references

Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zone

EXPERIMENTAL

Patients 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.

Combination Product: Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography

Interventions

Botulinum toxin guided by ultrasonography and anatomical references COMBINATION_PRODUCT

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.

Also known as: Botox injection

Botulinum neurotoxin guided by ultrasonography and anatomical references

Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography COMBINATION_PRODUCT

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.

Also known as: Botox injection, Linear electrode array electromyography

Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator
• Instituto Nacional de Rehabilitación Pedro Aguirre Cerda: collaborator

Study Sites (2)

Universidad de los Andes

Santiago, Las Condes, 7620001, Chile

Location

Instituto Nacional de Rehabilitación Pedro Aguirre Cerda

Santiago, Peñalolen, 7910250, Chile

Location

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• Sullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.

  PMID: 23997866 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Gait Disorders, Neurologic

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Rodrigo A Guzmán-Venegas, PhD

  Universidad de los Andes, Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The nature of the interventions makes blinding almost impossible. However, it will be possible to blind the support staff when they conduct the gait and functional evaluations. In the same way, the allocation of groups will be blinded at the time of performing the statistical analysis, which shall be performed by a third party.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: July 1, 2022
• Primary Completion: November 29, 2022
• Study Completion: December 4, 2022
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Previously mentioned data will be available 6 months after publication.
• Access Criteria: For access to research data, researchers must send a "data access statement" to the principal investigator (Rodrigo Guzmán-Venegas, rguzman@uandes.cl). This request must include as much information as possible about the use of the data. Also, it must include contact information (telephone number and e-mail to contact) on the petitioner.

Locations

CL (2)