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Completed

NCT Number: NCT06450457

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

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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Key information

Conditions

Cerebellar Ataxia Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Diseases Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT)

    Time frame: 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.

  2. Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT)

    Time frame: Baseline, 3 weeks

    Participants will be asked to walk as far as possible for 6 minutes. Longer distance walked shows better outcome.

Secondary outcomes

  1. Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA)

    Time frame: 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.

  2. Ability to Balance as Assessed by the Berg Balance Scale (BBS)

    Time frame: Baseline, 3 weeks

    Berg Balance Scale measures balance with a total score that ranges from 0 to 56. A higher score indicates better balance.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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