CompletedNot Applicable

Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.

United States23 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with first time unilateral stroke * 4 - 20 weeks post-stroke onset * resulting in hemiparesis with foot drop Exclusion Criteria: * Inability to receive a double adjustable AFO through their insurance * unable to follow two steps commands * unable to ambulate 20 feet with or without assistive device with a minimum level of assistance of contact guard assistance * diagnosis of cerebellar stroke * non ambulatory prior to stroke onset

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gait Endurance

Timeframe: at baseline

Gait Endurance

Timeframe: 1 week of practice with DA AFO and with PLS AFO randomly

Trial details

NCT IDNCT02693834

SponsorTexas Woman's University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04

Results submitted2019-02-21

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