Comparison of Two Botox Injection Techniques to Improve Gait

NCT ID: NCT07124806

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-12-04

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Botulinum neurotoxin guided by ultrasonography and anatomical references

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.

Group Type: ACTIVE_COMPARATOR

Botulinum toxin guided by ultrasonography and anatomical references

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

Botulinum toxin guided by ultrasonography and anatomical references

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.

Intervention Type: COMBINATION_PRODUCT

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Botox injection; Botox injection; Linear electrode array electromyography

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role: collaborator

Instituto Nacional de Rehabilitación Pedro Aguirre Cerda

UNKNOWN

Sponsor Role: collaborator

Universidad de los Andes, Chile

OTHER

Sponsor Role: lead

Responsible Party

RODRIGO AANTONIO GUZMAN

PT, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo A Guzmán-Venegas, PhD

Role: STUDY_DIRECTOR

Universidad de los Andes, Chile

Locations

Universidad de los Andes

Santiago, Las Condes, Chile

Instituto Nacional de Rehabilitación Pedro Aguirre Cerda

Santiago, Peñalolen, Chile

Countries

Chile

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Identifier Source: org_study_id