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

April 12, 2025 updated by: Kaitlin Benjamin, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High intensity stepping program
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.
Device: VECTOR 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.
Device: Polar H10 heart rate monitor
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.
Device: Therastride Treadmill System
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.
Other: Physical therapy
Physical therapy will be administered by a physical therapist and will include overground walking, treadmill walking, stairs, and resisted walking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 weeks
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.
Baseline, 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 weeks
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.
Baseline, 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kaitlin Benjamin, PT, DPT, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MH-23-1064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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