Assessment of Gait After Dysport Treatment

Completed · Phase 4

Conditions studied: Equinovarus; Acquired

In brief

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.

Key facts

Study ID

NCT03501043

Run by

Albert Einstein Healthcare Network

People needed

11

Starts

2018-06-11

Expected to finish

2019-08-22

Last updated by the study team

2020-03-02

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, aged ≥ 18
• Equinovarus foot deformity appropriate for botulinum toxin treatment (naïve or non-naïve)
• Modified Ashworth Scale between 1 to 3
• Women of reproductive potential must use effective contraception for the duration of the study

You may not qualify if…

• Inability to walk without leg brace
• Previous surgical intervention to affected/ankle/foot
• Uncontrolled seizures
• Pregnancy or lactation
• Known allergic reactions to Dysport
• Treatment with another investigational drug or other intervention in the past 4 months
• Modified Ashworth Scale 4
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
• Lower motor neuron disorder
• < Four months post botulinum toxin or serial casting

Where it is running

• MossRehab — Elkins Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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