CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Carbon Fiber Ankle Foot Orthosis (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/NCT03192046
NCT03192046N/ACompleted

Impact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PD

University of Texas Southwestern Medical Center·interventional·Posted Jun 19, 2017·Updated Mar 23, 2022

In Brief

A clinical study evaluating Carbon Fiber Ankle Foot Orthosis (AFO) and Standardized walking/exercise program for Gait Disorders, Neurologic and Parkinson Disease. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Parkinson disease (PD) is a progressive neurological disease that results in characteristic gait dysfunction. Gait problems include decreased velocity, decreased stride length, difficulty with initiation of gait, postural stability problems and alteration in joint kinematics.1 In this typically older patient population, these gait deviations affect their participation in household and community activities. The standard of care is currently focused on therapeutic exercise and cueing of various types (visual, auditory, verbal). Current interventions have not been demonstrated to markedly improve gait kinematics, so there is a need to identify interventions that could improve gait performance in this population. Lower extremity bracing is a common and well-established intervention for gait dysfunction with other populations, including stroke and brain injury. The braces allow for improved stability, sensory feedback, and consistent tactile cues to allow patients to have the best gait mechanics with each step. It is reasonable to hypothesize that appropriate bracing may have the potential to improve gait function and kinematics in PD since these patient often have gastroc-soleus weakness. Data from our early pilot studies indicates that bracing individuals with PD can positively impact their mobility. This includes improvements in velocity, step length, and dynamic balance. Additional data supported an upward trend in quality of life.

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 19, 2017
Enrollment StartSep 1, 2016
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.0 years ago

Interventions

Carbon Fiber Ankle Foot Orthosis (AFO)device

Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.

Standardized walking/exercise programother

standardized walking/exercise program without any brace or AFO