Trial Outcomes & Findings for Effects of High Intensity Stepping Training on Gait in Patients With Ataxia (NCT NCT06450457)

Results Overview

Participant is asked to walk a distance of 10 meters and the speed is measured by dividing the distance covered by the time taken.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Baseline, 3 weeks

Results posted on

2025-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	High Intensity Stepping Program The high intensity stepping training consists of a 1-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. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. 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. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. 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. This system allows for overground walking on a small indoor track.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Intensity Stepping Program n=4 Participants The high intensity stepping training consists of a 1-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. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. 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. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. 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. This system allows for overground walking on a small indoor track.
Age, Continuous	58.75 years n=4 Participants
Sex: Female, Male Female	0 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=4 Participants
Region of Enrollment United States	4 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Intensity Stepping Program n=4 Participants The high intensity stepping training consists of a 1-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. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. 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. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. 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. This system allows for overground walking on a small indoor track.
Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) Baseline	0.13 meters per second Standard Deviation 0.16
Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT) 3 weeks	0.60 meters per second Standard Deviation 0.31

PRIMARY outcome

Timeframe: Baseline, 3 weeks

Participants will be asked to walk as far as possible for 6 minutes. Longer distance walked shows better outcome.

Outcome measures

Outcome measures
Measure	High Intensity Stepping Program n=4 Participants The high intensity stepping training consists of a 1-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. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. 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. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. 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. This system allows for overground walking on a small indoor track.
Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) Baseline	145.26 feet Standard Deviation 177.34
Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT) 3 weeks	423.10 feet Standard Deviation 260.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Intensity Stepping Program n=4 Participants The high intensity stepping training consists of a 1-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. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. 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. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. 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. This system allows for overground walking on a small indoor track.
Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) Baseline	25.25 score on a scale Standard Deviation 7.80
Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA) 3 weeks	17.87 score on a scale Standard Deviation 9.15

SECONDARY outcome

Timeframe: Baseline, 3 weeks

Berg Balance Scale measures balance with a total score that ranges from 0 to 56. A higher score indicates better balance.

Outcome measures

Outcome measures
Measure	High Intensity Stepping Program n=4 Participants The high intensity stepping training consists of a 1-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. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. 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. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. 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. This system allows for overground walking on a small indoor track.
Ability to Balance as Assessed by the Berg Balance Scale (BBS) Baseline	9.50 score on a scale Standard Deviation 13.22
Ability to Balance as Assessed by the Berg Balance Scale (BBS) 3 weeks	20.00 score on a scale Standard Deviation 16.18

Adverse Events

High Intensity Stepping Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kaitlin Benjamin, PT, DPT

The University of Texas Health Science Center at Houston

Phone: 610-639-0431

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place