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

Cerebellar Ataxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450457
• Other study ID #: HSC-MH-23-1064
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: July 18, 2024

Study information

• Verified date: June 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Kaitlin Benjamin, PT, DPT
• Phone: 610-639-0431
• Email: Kaitlin.Benjamin[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of high intensity stepping training on gait outcome measures in patients with cerebellar ataxia, to identify the correlations between gait outcome measures and measures of ataxia and balance in individuals with cerebellar ataxia and to determine differences in response to high intensity stepping training based off of diagnosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 18, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• diagnosis of ataxia who were 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)

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia

Intervention

Device:
• Polar H10 heart rate monitor
Heart rate will be monitored utilizing 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
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 treadmill's 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
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Aerobic capacity and endurance 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 shoes better outcome	Baseline, 3 weeks
Secondary	Ataxia as assessed by the Scale for the Assessment and Rating of Ataxia (SARA)	It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).	Baseline, 3 weeks
Secondary	Ability to balance as assessed by the Berg Balance Scale (BBS)	It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function , for a maximum score of 56, higher score indicating better balance.	Baseline, 3 weeks