Phase 4
N=11
Assessment of Gait After Dysport Treatment
Equinovarus; Acquired
Bottom Line
View on ClinicalTrials.gov: NCT03501043 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Self-Selected Velocity (SSV) — 0.41; .48; 0.48; 0.52 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dysport (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein Healthcare Network
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Selected Velocity (SSV) |
0.41; .48; 0.48; 0.52 | — |
| PRIMARY Maximal Velocity |
.59; .71; .64; .78 | — |
| PRIMARY Step-length at Baseline and at Follow-up (Temporal-spatial Data) |
.47; .50; .50; .51 | — |
| SECONDARY Modified Ashworth Scale (MAS) at Baseline and at Follow-up |
2; 3; 1; 1 | — |
| SECONDARY Tardieu Scale (TS) at Baseline and at Follow-up |
3; 3; 1; 1 | — |
| SECONDARY Passive Range of Motion (PROM) at Baseline and at Follow-up |
44; 34; 50; 45.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03501043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.