Comparison of Two Botox Injection Techniques to Improve Gait

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

November 29, 2022

Study Completion Date

December 4, 2022

Conditions
Muscle SpasticityStroke SequelaeSpasticity as Sequela of StrokeGait Disorders, Neurologic
Interventions
COMBINATION_PRODUCT

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.

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.

Trial Locations (2)

7620001

Universidad de los Andes, Santiago

7910250

Instituto Nacional de Rehabilitación Pedro Aguirre Cerda, Santiago

All Listed Sponsors
collaborator

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

collaborator

Instituto Nacional de Rehabilitación Pedro Aguirre Cerda

UNKNOWN

lead

Universidad de los Andes, Chile

OTHER