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

NCT06450457 | Completed Results FDA Device

• 1 other identifier: HSC-MH-23-1064
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebellar Ataxia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

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

  Baseline, 3 weeks

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

  Baseline, 3 weeks

Study Arms (1)

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.

Device: Polar H10 heart rate monitor; Device: Therastride Treadmill System; Device: VECTOR Bioness; Other: Physical therapy

Interventions

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.

High intensity stepping program

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.

High intensity stepping program

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.

High intensity stepping program

Physical therapy OTHER

Physical therapy will be administered by a physical therapist and will include overground walking, treadmill walking, stairs, and resisted walking.

High intensity stepping program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cerebellar Ataxia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: Kaitlin Benjamin, PT, DPT
• Organization: The University of Texas Health Science Center at Houston

Kaitlin.Benjamin@memorialhermann.org

610-639-0431

Study Officials

• Kaitlin Benjamin, PT, DPT

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student, Principal Investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 10, 2024
• Study Start: March 26, 2024
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)