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Bracing for Walking in Parkinson's Disease

NCT03192046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-23

Study results available
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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.

Conditions

  • Gait Disorders, Neurologic
  • Parkinson Disease

Interventions

DEVICE

Carbon Fiber Ankle Foot Orthosis (AFO)

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

OTHER

Standardized walking/exercise program

standardized walking/exercise program without any brace or AFO

Sponsors & Collaborators

  • American Orthotic and Prosthetic Association

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Staci Shearin, Masters · UT Southwestern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192046 on ClinicalTrials.gov