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Modifications are being made to protocol
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The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.
This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankle foot orthosis fitting | Other | All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankle foot orthosis | Device | Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing | 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. | Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing | Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing | Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. | Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment |
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 |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center, School of Health Professions | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ankle Foot Orthosis Fitting | All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ankle Foot Orthosis Fitting | All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program. |
| 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 Step Length by Means of Computerized Gait Analysis From Initial to Final Testing | 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. | step length was analyzed from the GAITRite | Posted | Mean | Standard Deviation | cm | Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment |
|
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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 | Ankle Foot Orthosis Fitting | All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen McCain, PT, DPT, NCS | UT Southwestern Medical Center | 214-648-1559 | 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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|
| Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing | Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis. | EMG data was analyzed from 3 of the 4 participants | Posted | Number | participants | Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment. |
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| Other Pre-specified | Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing | Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. | data from 3 of the 4 participants was analyzed | Posted | Mean | Standard Deviation | meters | Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment |
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| 0 |
| 3 |
| 0 |
| 3 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |