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Carbon Fiber Ankle Foot Orthosis (AFO) for Neurologic Locomotion Disorder

N/A
Waitlist Available
Led By Staci Shearin, Masters
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Neurologic Locomotion Disorder
  • Neurologic Gait Disorders
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Gait Capacity as Assessed b 6-Minute Walk Test
Secondary study objectives
Change in Step Length
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Carbon Fiber Ankle Foot Orthosis (AFO)Experimental Treatment1 Intervention
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Group II: Control Group, Walking Program OnlyActive Control2 Interventions
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbon Fiber Ankle Foot Orthosis (AFO)
2016
N/A
~10

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,679 Total Patients Enrolled
American Orthotic and Prosthetic AssociationOTHER
4 Previous Clinical Trials
245 Total Patients Enrolled
Staci Shearin, MastersPrincipal InvestigatorUT Southwestern
~1 spots leftby Dec 2025