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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 is a NA study that has completed, run by Texas Woman's University. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02693834
The ClinicalTrials.gov registry entry for NCT02693834 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Woman's University, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Posterior Leaf spring AFO is the first listed.
NCT02693834 reports 0 study locations.
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.
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