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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Cerebellar Ataxia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06450457
HSC-MH-23-1064

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

High intensity stepping program
Experimental group
Description:
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.
Treatment:
Device: Polar H10 heart rate monitor
Device: VECTOR Bioness
Other: Physical therapy
Device: Therastride Treadmill System

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Kaitlin Benjamin, PT, DPT

Data sourced from clinicaltrials.gov

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