N/A
N=4
Effects of High Intensity Stepping Training on Gait in Patients With Ataxia
Cerebellar Ataxia
Bottom Line
View on ClinicalTrials.gov: NCT06450457 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) — 0.13; 0.60 meters per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Polar H10 heart rate monitor (Device); Therastride Treadmill System (Device); VECTOR Bioness (Device); Physical therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) |
0.13; 0.60 | — |
| PRIMARY Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) |
145.26; 423.10 | — |
| SECONDARY Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) |
25.25; 17.87 | — |
| SECONDARY Ability to Balance as Assessed by the Berg Balance Scale (BBS) |
9.50; 20.00 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT06450457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.