Gait Disorders, Neurologic, Parkinson Disease
Conditions
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
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
Sponsors
Study design
Intervention model description
This is a randomized, repeated measures, matched group study.
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Capacity as Assessed b 6-Minute Walk Test | Baseline and 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Step Length | Baseline and 6 months | 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. |
| Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | Baseline and 6 months | 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. |
Countries
United States
Contacts
UT Southwestern
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 9 |
Baseline characteristics
| Characteristic | Carbon Fiber Ankle Foot Orthosis (AFO) | Control Group, Walking Program Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Gait Speed | 107.6 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carbon Fiber Ankle Foot Orthosis (AFO) | Change in Gait Capacity as Assessed b 6-Minute Walk Test | 235.7 Feet | Standard Deviation 155.9 |
| Control Group, Walking Program Only | Change in Gait Capacity as Assessed b 6-Minute Walk Test | 150.0 Feet | Standard Deviation 270 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carbon Fiber Ankle Foot Orthosis (AFO) | Change in Step Length | 4.0 cm | Standard Deviation 1.8 |
| Control Group, Walking Program Only | Change in Step Length | 0.7 cm | Standard Deviation 9.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carbon Fiber Ankle Foot Orthosis (AFO) | Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | 21.7 Cm/sec | Standard Deviation 18.8 |
| Control Group, Walking Program Only | Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | 6.26 Cm/sec | Standard Deviation 10.7 |