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NCT01138995 · ClinicalTrials.gov registry record · NA
Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
A NA study, sponsored by Bioness.
- Completed
- Registry status
- NA
- Development phase
- 197
- Enrollment target
NCT01138995: Completed NA study, sponsored by Bioness.
NCT01138995 is a NA study that has completed, run by Bioness. The registered enrollment target is 197 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01138995, a NA study, has completed, sponsored by Bioness.
- COMPLETED
- Registry status
- NA
- Development phase
- 197 participants
- Enrollment target
Study Summary
The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.
Primary Outcome
Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm.
Interventions
- DEVICE Ness L300
- DEVICE Ankle-foot orthosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT01138995 record still lists
NCT01138995 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Ness L300 is the first listed.
NCT01138995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01138995 about?
NCT01138995 is a clinical study titled "Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop". The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.
What is the current status of trial NCT01138995?
This trial is currently completed. It is a NA study. The enrollment target is 197 participants. The study started on 2010-05. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01138995?
The interventions under investigation include: Ness L300 (DEVICE), Ankle-foot orthosis (DEVICE).
Who is sponsoring clinical trial NCT01138995?
This trial is sponsored by Bioness, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01138995's enrollment target sits among peer trials
197 567th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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