drugset / Trial / NCT03501043

Assessment of Gait After Dysport Treatment

NCT03501043 ↗

Phase 4 Completed 11 enrolled Albert Einstein Healthcare Network
NaSingle-groupOpen-labelTreatment

Summary

This pilot study will aim to understand the potential benefit of the assessment of walking using video slow motion for muscle selection and the development of an image catalogue guide of the potential results of injection of abobotulinumtoxinA by comparing foot postures before and after injection. The objective is to evaluate the use of video assessment to improve muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with equinovarus foot deformity who are able to ambulate will be included in the study. Dysport 1000 to 1500 units will be used to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors. The duration of subjects' participation is 4-6 weeks.

Timeline

Start
2018-06-11
Primary completion
2019-08-22
Completion
2019-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 1000 iu —
Subject Botulinum toxin type A Protein / enzyme biologic 1500 iu —

Indications