NCT03501043

Assessment of Gait After Dysport Treatment

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single arm, non-randomized clinical study with pre-post assessment to include post-stroke and Traumatic Brain Injury (TBI) outpatients with spastic ankle / foot muscles amenable to botulinum toxin injection. Subjects must be able to walk without braces. AbobotulinumtoxinA injection in a dose range of 500 to 1500 units one time to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors, knee flexors, tibialis posterior and long toe flexors.

Conditions

• Equinovarus; Acquired

Interventions

Type	Name	Description
DRUG	Dysport	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.

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-08-22
• Completion: 2019-08-22
• First posted: 2018-04-18
• Last updated: 2020-03-02
• Results posted: 2020-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study