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NCT03501043 · ClinicalTrials.gov registry record · Phase 4
Assessment of Gait After Dysport Treatment
A Phase 4 study, sponsored by Albert Einstein Healthcare Network.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03501043: Completed Phase 4 study, sponsored by Albert Einstein Healthcare Network.
NCT03501043 is a Phase 4 study that has completed, run by Albert Einstein Healthcare Network. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03501043, a Phase 4 study, has completed, sponsored by Albert Einstein Healthcare Network.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better.
Interventions
- DRUG Dysport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-06-11 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 4 |
What the finished NCT03501043 record still lists
NCT03501043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Dysport is the first listed.
NCT03501043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03501043 about?
NCT03501043 is a clinical study titled "Assessment of Gait After Dysport Treatment". 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. T...
What is the current status of trial NCT03501043?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2018-06-11. Estimated completion is 2019-08-22.
What interventions are being tested in trial NCT03501043?
The interventions under investigation include: Dysport (DRUG).
Who is sponsoring clinical trial NCT03501043?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03501043's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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