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| Name | Class |
|---|---|
| American Orthotic and Prosthetic Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon Fiber Ankle Foot Orthosis (AFO) | Experimental | 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. |
|
| Control Group, Walking Program Only | Active Comparator | The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon Fiber Ankle Foot Orthosis (AFO) | Device | Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Staci Shearin, Masters | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern | Dallas | Texas | 75235 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group, Walking Program Only | The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Feet | Baseline and 6 months |
|
Adverse data was collected throughout the entire study for each participant - 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. There were not any adverse events |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Staci Shearin | UtexasSouthwestern | 214-648-6564 | staci.shearin@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2017 | Dec 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a randomized, repeated measures, matched group study.
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| Standardized walking/exercise program | Other | standardized walking/exercise program without any brace or AFO |
|
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. |
| Baseline and 6 months |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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.
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | cm | Baseline and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Cm/sec | Baseline and 6 months |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. There were not any adverse events | 0 | 4 | 0 | 4 | 0 | 4 |
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| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |