Assessment of Gait After Dysport Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 1/13/2019 |
| Start Date: | June 11, 2018 |
| End Date: | May 30, 2020 |
| Contact: | Alberto Esquenazi, MD |
| Email: | aesquena@einstein.edu |
| Phone: | 215-663-6676 |
Video and Temporal Spatial Parameters Assessment of Gait After Dysport Treatment. A Pilot Study
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.
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.
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 1000 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.
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 1000 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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