Cerebellar Ataxia
Conditions
Brief summary
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.
Interventions
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.
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.
DEVICEVECTOR Bioness
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.
OTHERPhysical therapy
Physical therapy will be administered by a physical therapist and will include overground walking, treadmill walking, stairs, and resisted walking.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of ataxia * admitted to The Institute for Rehabilitation and Research (TIRR) Texas Medical Center (TMC) Inpatient or TIRR Kirby Glenn Outpatient * pathology that primarily affects the brain/cerebellum, including degenerative diseases, stroke, traumatic brain injury (TBI), posterior fossa tumor, and multiple sclerosis (MS) * ambulatory at initial evaluation or will have functional ambulation goals at initial evaluation (as noted by 10 meter walk test and 6 minute walk test measures documented as 0) * chronicity of injury will be of at least 1 month or greater
Exclusion criteria
* diagnoses that may have cerebellar involvement but without cerebellar ataxia as a principal impairment such as autism, down syndrome, schizophrenia, etc * non ambulatory or who are not able to participate in high intensity stepping training due to cardiac involvement (such as cardiac rehabilitation parameters) or due to orthopedic limitations (such as weight bearing parameters)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) | Baseline, 3 weeks | Participant is asked to walk a distance of 10 meters and the speed is measured by dividing the distance covered by the time taken. |
| Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) | Baseline, 3 weeks | Participants will be asked to walk as far as possible for 6 minutes. Longer distance walked shows better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) | Baseline, 3 weeks | 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. |
| Ability to Balance as Assessed by the Berg Balance Scale (BBS) | Baseline, 3 weeks | Berg Balance Scale measures balance with a total score that ranges from 0 to 56. A higher score indicates better balance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | High Intensity Stepping Program | — |
|---|---|---|
| Age, Continuous | 58.75 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 4 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: Baseline, 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Stepping Program | Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) | Baseline | 145.26 feet | Standard Deviation 177.34 |
| High Intensity Stepping Program | Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) | 3 weeks | 423.10 feet | Standard Deviation 260.55 |
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.
Time frame: Baseline, 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Stepping Program | Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) | Baseline | 0.13 meters per second | Standard Deviation 0.16 |
| High Intensity Stepping Program | Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) | 3 weeks | 0.60 meters per second | Standard Deviation 0.31 |
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.
Time frame: Baseline, 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Stepping Program | Ability to Balance as Assessed by the Berg Balance Scale (BBS) | Baseline | 9.50 score on a scale | Standard Deviation 13.22 |
| High Intensity Stepping Program | Ability to Balance as Assessed by the Berg Balance Scale (BBS) | 3 weeks | 20.00 score on a scale | Standard Deviation 16.18 |
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.
Time frame: Baseline, 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Stepping Program | Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) | Baseline | 25.25 score on a scale | Standard Deviation 7.8 |
| High Intensity Stepping Program | Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) | 3 weeks | 17.87 score on a scale | Standard Deviation 9.15 |