CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Posterior Leaf spring AFO +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02693834
NCT02693834N/ACompleted

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

Texas Woman's University·interventional·Posted Feb 29, 2016·Updated Feb 28, 2020

In Brief

A clinical study evaluating Posterior Leaf spring AFO and Double adjustable AFO for Stroke and 4 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 29, 2016
Enrollment StartJan 1, 2016
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.3 years ago

Interventions

Posterior Leaf spring AFOdevice

Posterior Leaf Spring AFO is an over the shelf polypropylene ankle foot orthosis to assist foot drop.

Double adjustable AFOdevice

Double adjustable AFO is a custom AFO with double action metal upright joints