Parkinson's Disease
Conditions
Keywords
gait, Parkinson's disease
Brief summary
The purpose of this study is to investigate the impact of a specifically designed leg brace on walking endurance in individuals with Parkinson's disease.
Detailed description
This is a randomized, repeated measures, matched group study. There will be three groups of participants, 20 participants per group, 60 participants total. Group one (G1) will receive custom-fabricated bilateral braces and a standardized home walking/exercise program. Group two (G2) will receive an off-the shelf ankle support and standardized home walking/exercise program. Group three (G3) will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. Subjects will be followed for one year during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 6 months for the duration of the study for testing as well as for other visits as noted in the table below.
Interventions
OTHERWalking program with ankle brace
Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.
OTHERIndividualized walking program
Walking program will include instructions on walking activities at home such as time of walking
OTHERWalking program with custom braces.
Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 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 90. 3. Ability to walk 150 feet independently over level surfaces with or without an assistive device. 4. Hoehn and Yahr stage 1-4. 5. Less than 10 full heel raises in single limb stance bilaterally. 6. Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Distance Walked on 6-Minute Walk Test (6MWT) | 6MWT will be done at initial testing and 12 months | Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | Testing will be done at initial testing and 12 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 temporal and spatial parameters. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Activity as Measured by Steps Per Day | Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 months | Participants will be asked to wear a pedometer for 7 days at designated times in study. Total steps per day will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Walking Program With Ankle Brace This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on. | 4 |
| Individualized Walking Program This group will receive a customized walking program.
Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking | 4 |
| Walking Program With Custom Braces This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on. | 5 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to follow up | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Individualized Walking Program | Walking Program With Custom Braces | Walking Program With Ankle Brace | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Age, Continuous | 71 years | 70 years | 62 years | 68 years |
| Region of Enrollment United States | 4 Participants | 5 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 | 0 / 2 |
Outcome results
Primary
Change in Distance Walked on 6-Minute Walk Test (6MWT)
Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
Time frame: 6MWT will be done at initial testing and 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Walking Program With Ankle Brace | Change in Distance Walked on 6-Minute Walk Test (6MWT) | 261 feet |
| Individualized Walking Program | Change in Distance Walked on 6-Minute Walk Test (6MWT) | 56 feet |
| Walking Program With Custom Braces | Change in Distance Walked on 6-Minute Walk Test (6MWT) | 31 feet |
Secondary
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
Participants 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 parameters.
Time frame: Testing will be done at initial testing and 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Walking Program With Ankle Brace | Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | 22 cm/sec |
| Individualized Walking Program | Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | 5 cm/sec |
| Walking Program With Custom Braces | Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | 3 cm/sec |
Other Pre-specified
Change in Daily Activity as Measured by Steps Per Day
Participants will be asked to wear a pedometer for 7 days at designated times in study. Total steps per day will be recorded.
Time frame: Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 months
Population: This was a self-reported data set. Patients had logs to record daily steps from pedometers for each week. Data was not reported accurately from all participants, thus data set is incomplete. Analysis cannot be completed.