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NCT02693834 · ClinicalTrials.gov registry record · NA
Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.
A NA study, sponsored by Texas Woman's University.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT02693834: Completed NA study, sponsored by Texas Woman's University.
NCT02693834 is a NA study that has completed, run by Texas Woman's University. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02693834, a NA study, has completed, sponsored by Texas Woman's University.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
PURPOSE: The purpose of this study will be to identify whether patients in the subacute stage of stroke, who demonstrate foot drop, will have better gait outcomes when using a Double Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to determine whether one week of practice significantly changes gait outcomes with either of the AFO conditions. INCLUSION CRITERIA: Twenty participants over the age of 18, of any gender and ethnicity, diagnosed with first time unilateral stroke, 4 - 20 weeks post-stroke onset, resulting in hemiparesis with foot drop will be recruited for this study. EXCLUSION CRITERIA: 1. Not able to receive a double adjustable AFO through their insurance 2. Unable to follow two steps commands 3. Unable to ambulate 20 feet with or without assistive device with a minimum level of assistance of contact guard assistance. 4. Cerebellar Stroke 5. Inability to ambulate prior to stroke 6. receiving chemotherapy at the time of study OUTCOME MEASURES: 1. Six Minute walk test 2. Gait Symmetry and Gait velocity measured with GAITRite for self paced velocity walk and fast paced velocity walk. DATA COLLECTION: Data will be collected three times over two weeks period. First Visit: Demographics, Fugl-Meyer Lower Extremity Assessment of sensorimotor function, Mini Mental State Examination 6MWT and GAITRite measurements using Both types of AFO in a random order. Afterwards participant will be given one type of AFO (randomly selected) to practice walking for a week. Second Visit: 6MWT and GAITRite measurements using the type of AFO they were practicing with. Then the other type of AFO will be given to practice walking for a week. Third Visit: 6MWT and GAITRite measurements using the second type of AFO that they were practicing with the week prior. Patient will be asked which type of AFO they prefer to use.
Primary Outcome
6 Minute Walk test (6MWT) to assess gait endurance using DA AFO and PLS AFO
Interventions
- DEVICE Posterior Leaf spring AFO
- DEVICE Double adjustable AFO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-04 |
| Phase | NA |
What the finished NCT02693834 record still lists
NCT02693834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Posterior Leaf spring AFO is the first listed.
NCT02693834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02693834 about?
NCT02693834 is a clinical study titled "Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.". PURPOSE: The purpose of this study will be to identify whether patients in the subacute stage of stroke, who demonstrate foot drop, will have better gait outcomes when using a Double Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to determine whether one week of practice...
What is the current status of trial NCT02693834?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2016-01. Estimated completion is 2018-04.
What interventions are being tested in trial NCT02693834?
The interventions under investigation include: Posterior Leaf spring AFO (DEVICE), Double adjustable AFO (DEVICE).
Who is sponsoring clinical trial NCT02693834?
This trial is sponsored by Texas Woman's University, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02693834's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 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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