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Bracing for Walking in Parkinson's Disease

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03192046
Enrollment
10
Registered
2017-06-19
Start date
2016-09-01
Completion date
2020-12-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Disorders, Neurologic, Parkinson Disease

Brief 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.

Detailed description

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.

Interventions

DEVICECarbon Fiber Ankle Foot Orthosis (AFO)

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

OTHERStandardized walking/exercise program

standardized walking/exercise program without any brace or AFO

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER
American Orthotic and Prosthetic Association
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a randomized, repeated measures, matched group study.

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5 2. Age between 30 and 85. 3. Measurable decrement in gait velocity (between 35 and 15 percent below age-predicted norms for self-selected walking velocity) as measured by the 6 MWT 4. Hoehn and Yahr stage 2-3. 5. Less than 10 full heel raises in single limb stance bilaterally.

Exclusion criteria

1. Body mass index greater than 40. 2. Passive dorsiflexion range of motion less than approximately neutral (90 degrees) 3. Any other uncontrolled health condition for which gait training is contraindicated 4. Self-report of \> 1 fall/month 5. A score of 11 or less on the Short Orientation-Memory-Concentration Test of Cognitive Impairment

Design outcomes

Primary

MeasureTime frameDescription
Change in Gait Capacity as Assessed b 6-Minute Walk TestBaseline and 6 monthsThe 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).

Secondary

MeasureTime frameDescription
Change in Step LengthBaseline and 6 monthsParticipants 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.
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis SystemBaseline and 6 monthsEach 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStaci Shearin, Masters

UT Southwestern

Participant flow

Participants by arm

ArmCount
Carbon Fiber Ankle Foot Orthosis (AFO)
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. Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
5
Control Group, Walking Program Only
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT. Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
4
Total9

Baseline characteristics

CharacteristicCarbon Fiber Ankle Foot Orthosis (AFO)Control Group, Walking Program OnlyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants2 Participants5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants2 Participants4 Participants
Gait Speed107.6 cm/sec
STANDARD_DEVIATION 11.12
106.4 cm/sec
STANDARD_DEVIATION 4.84
106.9 cm/sec
STANDARD_DEVIATION 7.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants3 Participants8 Participants
Region of Enrollment
United States
5 Participants4 Participants9 Participants
Sex: Female, Male
Female
2 Participants0 Participants2 Participants
Sex: Female, Male
Male
3 Participants4 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 4
other
Total, other adverse events
0 / 50 / 4
serious
Total, serious adverse events
0 / 50 / 4

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Carbon Fiber Ankle Foot Orthosis (AFO)Change in Gait Capacity as Assessed b 6-Minute Walk Test235.7 FeetStandard Deviation 155.9
Control Group, Walking Program OnlyChange in Gait Capacity as Assessed b 6-Minute Walk Test150.0 FeetStandard Deviation 270
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Carbon Fiber Ankle Foot Orthosis (AFO)Change in Step Length4.0 cmStandard Deviation 1.8
Control Group, Walking Program OnlyChange in Step Length0.7 cmStandard Deviation 9.6
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Carbon Fiber Ankle Foot Orthosis (AFO)Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System21.7 Cm/secStandard Deviation 18.8
Control Group, Walking Program OnlyChange in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System6.26 Cm/secStandard Deviation 10.7

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026