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NCT03192046 · ClinicalTrials.gov registry record · NA
Bracing for Walking in Parkinson's Disease
A NA study of Parkinson Disease and Gait Disorders, Neurologic, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03192046: Completed NA study of Parkinson Disease and Gait Disorders, Neurologic, sponsored by University of Texas Southwestern Medical Center.
NCT03192046 is a NA study of Parkinson Disease and Gait Disorders, Neurologic that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 10 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03192046, a NA study of Parkinson Disease and Gait Disorders, Neurologic, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The 6 Minute Walk Test (6MWT) is a test of walking (gait) endurance and walking velocity and measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at 6 months. While the total distance cover
Conditions Studied
Interventions
- DEVICE Carbon Fiber Ankle Foot Orthosis (AFO)
- OTHER Standardized walking/exercise program
Study Locations (1)
Texas
- UT Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-09 |
| Est. Completion | 2020-12 |
| Phase | NA |
What the finished NCT03192046 record still lists
NCT03192046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Carbon Fiber Ankle Foot Orthosis (AFO) is the first listed.
NCT03192046 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03192046 about?
NCT03192046 is a clinical study titled "Bracing for Walking in Parkinson's Disease". 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 olde...
What is the current status of trial NCT03192046?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2016-09. Estimated completion is 2020-12.
What conditions does trial NCT03192046 study?
This clinical trial studies the following conditions: Parkinson Disease, Gait Disorders, Neurologic.
What interventions are being tested in trial NCT03192046?
The interventions under investigation include: Carbon Fiber Ankle Foot Orthosis (AFO) (DEVICE), Standardized walking/exercise program (OTHER).
Who is sponsoring clinical trial NCT03192046?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03192046 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03192046's enrollment target sits among peer trials
10 276th of 297 higher than 11 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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