An interventional study of Carbon Fiber Ankle Foot Orthosis (AFO) and Standardized walking/exercise program in Gait Disorders, Neurologic and Parkinson Disease, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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.
This is a randomized, repeated measures, matched group study. There will be two groups of participants, 8 participants per group, 35 participants total from time of initial enrollment in this study. Group one (G1) will receive bilateral custom braces and a standardized home walking/exercise program. Group two will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. At the time of consent, random drawing from concealed envelopes with red, blue or green chips will be done to determine group assignment. Subjects will be recruited through the Clinical Center for Movement Disorders at UT Southwestern Medical Center where patients with PD receive routine evaluation and follow-up. Subjects will be followed for 6 months during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 3 months for the duration of the study for testing as well as for other visits as noted in the table below. Participants will not need to have insurance benefits for initial physical therapy evaluation and for ankle braces. All subsequent visits to the Crowley gait lab for assessments and brace adjustment will be provided at no cost to the participants.
327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 246 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion Criteria:
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.
Device: Carbon Fiber Ankle Foot Orthosis (AFO)
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Other: Standardized walking/exercise program
Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
standardized walking/exercise program without any brace or AFO
Change in Gait Capacity as Assessed b 6-Minute Walk Test
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 covered during six minutes (6MWTD) is often used as the standard measurement of gait capacity (i.e., the maximum distance one can achieve), the endurance (i.e., ability to maintain speed over a prolonged time) can be inferred by the gait speed trajectory (GST) during the 6MW test (6MWGST).
Time frame: Baseline and 6 months
Change in Step Length
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
Time frame: Baseline and 6 months
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
Each subject will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze temporal and spatial gait parameters.
Time frame: Baseline and 6 months
| Milestone | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only |
|---|---|---|
| Started | 5 | 4 |
| Completed | 4 | 3 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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 covered during six minutes (6MWTD) is often used as the standard measurement of gait capacity (i.e., the maximum distance one can achieve), the endurance (i.e., ability to maintain speed over a prolonged time) can be inferred by the gait speed trajectory (GST) during the 6MW test (6MWGST).
| Feet | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only |
|---|---|---|
| Change in Gait Capacity as Assessed b 6-Minute Walk Test | 235.7 ± 155.9 | 150.0 ± 270.0 |
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
| cm | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only |
|---|---|---|
| Change in Step Length | 4.0 ± 1.8 | 0.7 ± 9.6 |
Each subject will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze temporal and spatial gait parameters.
| Cm/sec | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only |
|---|---|---|
| Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | 21.7 ± 18.8 | 6.26 ± 10.7 |
Collected over Adverse data was collected throughout the entire study for each participant - 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carbon Fiber Ankle Foot Orthosis (AFO) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Control Group, Walking Program Only | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 3 | 2 | 5 |
| Sex: Female, Male(Participants) | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 3 | 4 | 7 |
| Race (NIH/OMB)(Participants) | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 5 | 3 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only | Total |
|---|---|---|---|
| United States | 5 | 4 | 9 |
| Gait Speed(cm/sec) | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only | Total |
|---|---|---|---|
| Mean | 107.6 ± 11.12 | 106.4 ± 4.84 | 106.9 ± 7.7 |
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University of Texas Southwestern Medical Center