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The purpose of this study is to examine the effects of high intensity stepping training on gait recovery, including walking speed and endurance, in patients with cerebellar ataxia. The hypothesis is that there will be a significant improvement in gait outcome measures (6 Minute Walk Test and 10 Meter Walk Test) in patients who receive high-intensity stepping training during physical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity stepping program | Experimental | The high intensity stepping training consists of a one-hour long physical therapy session administered by a physical therapist, and it will include overground walking, treadmill walking (with or without bodyweight support), stairs, and resisted walking. Heart rate will be monitored with the Polar heart rate monitor, with the goal of reaching moderate to high intensity for 30 minutes during the one hour-long physical therapy session. The training may involve the use of the Therastride Treadmill System or the VECTOR Bioness, and the device used will be determined by how much assistance the participant needs. If a participant is already ambulating and doesn't need assistance, then that participant won't use any equipment other than a Polar heart rate monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polar H10 heart rate monitor | Device | Heart rate will be monitored using a Polar H10 heart rate monitor, with the goal of reaching moderate to high intensity for 30 minutes during the one hour long therapy intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) | Participant is asked to walk a distance of 10 meters and the speed is measured by dividing the distance covered by the time taken. | Baseline, 3 weeks |
| Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) | Participants will be asked to walk as far as possible for 6 minutes. Longer distance walked shows better outcome. | Baseline, 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) | Scale for the Assessment and Rating of Ataxia (SARA) measures ataxia with a total score that ranges from 0 (no ataxia) to 40 (most severe ataxia). A higher score indicates a worse outcome. | Baseline, 3 weeks |
| Ability to Balance as Assessed by the Berg Balance Scale (BBS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaitlin Benjamin, PT, DPT | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Intensity Stepping Program | The high intensity stepping training consists of a 1-hour long physical therapy session administered by a physical therapist, and it will include overground walking, treadmill walking (with or without bodyweight support), stairs, and resisted walking. Heart rate will be monitored with the Polar heart rate monitor, with the goal of reaching moderate to high intensity for 30 minutes during the one hour-long physical therapy session. The training may involve the use of the Therastride Treadmill System or the VECTOR Bioness, and the device used will be determined by how much assistance the participant needs. If a participant is already ambulating and doesn't need assistance, then that participant won't use any equipment other than a Polar heart rate monitor. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. This system allows for overground walking on a small indoor track. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Intensity Stepping Program | The high intensity stepping training consists of a 1-hour long physical therapy session administered by a physical therapist, and it will include overground walking, treadmill walking (with or without bodyweight support), stairs, and resisted walking. Heart rate will be monitored with the Polar heart rate monitor, with the goal of reaching moderate to high intensity for 30 minutes during the one hour-long physical therapy session. The training may involve the use of the Therastride Treadmill System or the VECTOR Bioness, and the device used will be determined by how much assistance the participant needs. If a participant is already ambulating and doesn't need assistance, then that participant won't use any equipment other than a Polar heart rate monitor. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. This system allows for overground walking on a small indoor track. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) | Participant is asked to walk a distance of 10 meters and the speed is measured by dividing the distance covered by the time taken. | Posted | Mean | Standard Deviation | meters per second | Baseline, 3 weeks |
|
Up to 3 weeks
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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 | High Intensity Stepping Program | The high intensity stepping training consists of a 1-hour long physical therapy session administered by a physical therapist, and it will include overground walking, treadmill walking (with or without bodyweight support), stairs, and resisted walking. Heart rate will be monitored with the Polar heart rate monitor, with the goal of reaching moderate to high intensity for 30 minutes during the one hour-long physical therapy session. The training may involve the use of the Therastride Treadmill System or the VECTOR Bioness, and the device used will be determined by how much assistance the participant needs. If a participant is already ambulating and doesn't need assistance, then that participant won't use any equipment other than a Polar heart rate monitor. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. This system allows for overground walking on a small indoor track. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaitlin Benjamin, PT, DPT | The University of Texas Health Science Center at Houston | 610-639-0431 | Kaitlin.Benjamin@memorialhermann.org |
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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 | Mar 5, 2024 | Apr 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002524 | Cerebellar Ataxia |
| ID | Term |
|---|---|
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Therastride Treadmill System | Device | Participants will be asked to walk on the Therastride Treadmill for 30 minutes.This treadmill can unweight patients so that the task of walking becomes easier. The body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight for the purposes of this study. |
|
| VECTOR Bioness | Device | Participants will be asked to walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. This system can unweight patients so that the task of walking becomes easier. The body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight for the purposes of this study. This system allows for overground walking on a small indoor track as opposed to walking on a treadmill. |
|
| Physical therapy | Other | Physical therapy will be administered by a physical therapist and will include overground walking, treadmill walking, stairs, and resisted walking. |
|
Berg Balance Scale measures balance with a total score that ranges from 0 to 56. A higher score indicates better balance. |
| Baseline, 3 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
| Primary | Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) | Participants will be asked to walk as far as possible for 6 minutes. Longer distance walked shows better outcome. | Posted | Mean | Standard Deviation | feet | Baseline, 3 weeks |
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| Secondary | Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) | Scale for the Assessment and Rating of Ataxia (SARA) measures ataxia with a total score that ranges from 0 (no ataxia) to 40 (most severe ataxia). A higher score indicates a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 weeks |
|
|
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| Secondary | Ability to Balance as Assessed by the Berg Balance Scale (BBS) | Berg Balance Scale measures balance with a total score that ranges from 0 to 56. A higher score indicates better balance. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 weeks |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |