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Inadequate funding to continue the study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking program with ankle brace | Experimental | This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program. |
|
| Individualized walking program | Experimental | This group will receive a customized walking program. |
|
| Walking program with custom braces | Experimental | This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking program with ankle brace | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6MWT will be done at initial testing and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Testing will be done at initial testing and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen J McCain, DPT | UTSW Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| 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 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. | Posted | Mean | Full Range | feet | 6MWT will be done at initial testing and 12 months |
|
2 years
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen McCain, PT, DPT, NCS | University of Texas Southwestern Medical Center | 2146481559 | karen.mccain@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Individualized walking program | Other | Walking program will include instructions on walking activities at home such as time of walking |
|
| Walking program with custom braces. | Other | 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. |
|
| 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| 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. | Posted | Mean | Full Range | cm/sec | Testing will be done at initial testing and 12 months |
|
|
|
| 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. | 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. | Posted | 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 |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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 | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |