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Effects of High Intensity Stepping Training on Gait in Patients With Ataxia

Not Applicable
Completed
Conditions
Cerebellar Ataxia
Interventions
Device: Polar H10 heart rate monitor
Device: Therastride Treadmill System
Device: VECTOR Bioness
Registration Number
NCT06450457
Lead Sponsor
The University of Texas Health Science Center, Houston
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
High intensity stepping programVECTOR BionessThe arm involves the use of the Polar heart rate monitor, the Therastride Treadmill System, OR the VECTOR Bioness * The device utilized will be determine by how much assistance the participant needs. * Some participants will not be utilizing any equipment other than a Polar heart rate monitor to collect heart rate data if they are already ambulating.
High intensity stepping programTherastride Treadmill SystemThe arm involves the use of the Polar heart rate monitor, the Therastride Treadmill System, OR the VECTOR Bioness * The device utilized will be determine by how much assistance the participant needs. * Some participants will not be utilizing any equipment other than a Polar heart rate monitor to collect heart rate data if they are already ambulating.
High intensity stepping programPolar H10 heart rate monitorThe arm involves the use of the Polar heart rate monitor, the Therastride Treadmill System, OR the VECTOR Bioness * The device utilized will be determine by how much assistance the participant needs. * Some participants will not be utilizing any equipment other than a Polar heart rate monitor to collect heart rate data if they are already ambulating.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

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