CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Dysportdrug
Likely dose
Dysport 1500 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03501043
NCT03501043Phase 4Completed

Video and Temporal Spatial Parameters Assessment of Gait After Dysport Treatment. A Pilot Study

Albert Einstein Healthcare Network·interventional·Posted Apr 18, 2018·Updated Mar 2, 2020

In Brief

A Phase 4 clinical trial evaluating Dysport for Equinovarus; Acquired. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 18, 2018
Enrollment StartJun 11, 2018
Primary CompletionAug 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.2 years ago

Interventions

Dysportdrug

Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors.