Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.
Public ClinicalTrials.gov record NCT02693834. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02693834
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2015
- Primary completion
- Mar 31, 2018
- Completion
- Mar 31, 2018
- Last update posted
- Feb 27, 2020
2016 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baylor Institute for rehabilitation | Frisco | Texas | 75034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02693834, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2020 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02693834 live on ClinicalTrials.gov.