Comparison of Two Botox Injection Techniques to Improve Gait

Universidad de los Andes, Chile

Status: Completed

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

Treatments: Combination Product: Botulinum toxin guided by ultrasonography and anatomical references; Combination Product: Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography

Study type: Interventional

Funder types: Other

Identifiers

NCT07124806

UAndes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Botulinum neurotoxin guided by ultrasonography and anatomical references

Active Comparator group

Description:

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.

Treatment:

Combination Product: Botulinum toxin guided by ultrasonography and anatomical references

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

Experimental group

Description:

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.

Treatment:

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