Cerebellar DisordersVITALNCT07621978
Variable Intense Training for Ataxia and Locomotion
A study testing High-intensity training in variable contexts and Conventional balance training in people with Cerebellar Disorders and Cerebellar Degeneration, run by Indiana University.
Trial summary
The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebellar Disorders, Cerebellar Degeneration, Cerebellar Atrophy
- What is being tested?
- High-intensity training in variable contexts and Conventional balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-85
- >6 months following brain injury or diagnosis of cerebellar dysfunction
- A total score of > 4 on items 5-8 on the SARA for the ipsilateral limb
- Ability to ambulate 10 m at self-selected gait speeds (SSV) <1.2 m/s with no greater than minimal physical assistance permitted for postural stability only, but with below knee bracing and/or assistive device as needed
- Weight < 350 pounds
- Able to follow 1-step command
- Medical clearance to participate
Who cannot join
- Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
- Currently participating in other physical therapy
- >50 units of Botox within the past three months in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis
- Individuals deemed not stable between Pre-Baseline Testing and Baseline Testing
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Potential Efficacy of High-intensity Gait Training in Individuals With Cerebellar Damage
The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease
Read the detailed description
The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease
- Being tested
- High-intensity training in variable contexts, Conventional balance training
- Keywords
- Cerebellar diseases, high-intensity training
- Medical subject headings
- Cerebellar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity training in variable contextsOther
Also called Locomotor training at higher intensities
High intensity stepping training: Training sessions will focus on maximizing stepping activities in variable contexts while targeting ≥70% HR reserve (or approximately 80% age-predicted maximum HR) calculated using the Karvonen formula. Target HR will be decreased by 10 beats if the individual is on beta-blockers. Intensity will also be monitored using the Borg RPE scale every 3-5 minutes with goals of ≥15 on a 6-20 scale. The intensity of the walking training will be primarily modulated through the treadmill speed and incline as well as addition of weights to the torso or limbs for the purpose of error augmentation and not to dampen ataxia. Sessions will focus on achieving up to 40 minutes of stepping training within each 60-minute session. Potential tasks include walking in multiple directions, over inclines and obstacles, and/or with weighted vests and leg weights with limited handrail use as tolerated and decided by the therapist and participant.
Conventional balance trainingOther
Also called Static and dynamic stability training
Conventional training: Training sessions will focus on improving static and dynamic balance, while calculated using the Karvonen formula. Target HR ranges will be decreased by 10 beats if the individual is on beta-blockers. Intensity will also be monitored using heart rates and RPE every 3-5 minutes with goals of <14 on a 6-20 scale. Sessions will focus on balance training for up to 40 minutes within a 60-minute session. Individuals will perform ~10 minutes (~25% of sessions) on balance activities in the sitting position, ~20 minutes (50% of sessions) of standing positions and ~10 minutes (25% of sessions) of walking training.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity training in variable contexts | Experimental | High-intensity training focused on stepping tasks in variable contexts (tasks and environments) while targeting higher cardiovascular intensity (>75% maximum predicted heart rates) during up to 40 mins of 1-hr sessions. A total of 20 sessions will be targeted. Receives: Other: High-intensity training in variable contexts |
| Conventional balance training | Active comparator | Conventional balance activities will consist of sitting and standing balance exercises, with selected dynamic stability exercises performed during walking tasks. Heart rates will be monitored with no targeted range. All sessions will be 1-hr long with balance activities for up to 40 minutes per session. A total of 20 sessions will be targeted. Receives: Other: Conventional balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-min walk test
Participants will walk for 6 minutes with instructions to "cover as much ground as they can".
Measured: Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebellar DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled cross-over trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- Thomas G Hornby, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621978
- Sponsor's protocol ID
- IU31611
- Acronym
- VITAL
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keller JL, Bastian AJ. A home balance exercise program improves walking in people with cerebellar ataxia. Neurorehabil Neural Repair. 2014 Oct;28(8):770-8. doi: 10.1177/1545968314522350. Epub 2014 Feb 13.
PubMed 24526707Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
PubMed 31434543
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Potential Efficacy of High-intensity Gait Training in Individuals With Cerebellar Damage
- ClinicalTrials.gov ID
- NCT07621978
- Acronym / sponsor ID
- VITAL / IU31611
- Keywords
- Cerebellar diseases, high-intensity training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease
Detailed description
The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled cross-over trial
| Arm | Type | Receives |
|---|---|---|
| High-intensity training in variable contexts | Experimental | Other: High-intensity training in variable contextsHigh-intensity training focused on stepping tasks in variable contexts (tasks and environments) while targeting higher cardiovascular intensity (>75% maximum predicted heart rates) during up to 40 mins of 1-hr sessions. A total of 20 sessions will be targeted. |
| Conventional balance training | Active comparator | Other: Conventional balance trainingConventional balance activities will consist of sitting and standing balance exercises, with selected dynamic stability exercises performed during walking tasks. Heart rates will be monitored with no targeted range. All sessions will be 1-hr long with balance activities for up to 40 minutes per session. A total of 20 sessions will be targeted. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ages 18-85
- >6 months following brain injury or diagnosis of cerebellar dysfunction
- A total score of > 4 on items 5-8 on the SARA for the ipsilateral limb
- Ability to ambulate 10 m at self-selected gait speeds (SSV) <1.2 m/s with no greater than minimal physical assistance permitted for postural stability only, but with below knee bracing and/or assistive device as needed
- Weight < 350 pounds
Key exclusion criteria (4 listed)
- Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
- Currently participating in other physical therapy
- >50 units of Botox within the past three months in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis
- Individuals deemed not stable between Pre-Baseline Testing and Baseline Testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity training in variable contextsAlso: Locomotor training at higher intensitiesHigh intensity stepping training: Training sessions will focus on maximizing stepping activities in variable contexts while targeting ≥70% HR reserve (or approximately 80% age-predicted maximum HR) calculated using the Karvonen formula. Target HR will be decreased by 10 beats if the individual is on beta-blockers. Intensity will also be monitored using the Borg RPE scale every 3-5 minutes with goals of ≥15 on a 6-20 scale. The intensity of the walking training will be primarily modulated through the treadmill speed and incline as well as addition of weights to the torso or limbs for the purpose of error augmentation and not to dampen ataxia. Sessions will focus on achieving up to 40 minutes of stepping training within each 60-minute session. Potential tasks include walking in multiple directions, over inclines and obstacles, and/or with weighted vests and leg weights with limited handrail use as tolerated and decided by the therapist and participant. | Other | High-intensity training in variable contexts |
| Conventional balance trainingAlso: Static and dynamic stability trainingConventional training: Training sessions will focus on improving static and dynamic balance, while calculated using the Karvonen formula. Target HR ranges will be decreased by 10 beats if the individual is on beta-blockers. Intensity will also be monitored using heart rates and RPE every 3-5 minutes with goals of <14 on a 6-20 scale. Sessions will focus on balance training for up to 40 minutes within a 60-minute session. Individuals will perform ~10 minutes (~25% of sessions) on balance activities in the sitting position, ~20 minutes (50% of sessions) of standing positions and ~10 minutes (25% of sessions) of walking training. | Other | Conventional balance training |
Primary outcome
6-min walk test
Time frame: Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks
Participants will walk for 6 minutes with instructions to "cover as much ground as they can".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 24526707Keller JL, Bastian AJ. A home balance exercise program improves walking in people with cerebellar ataxia. Neurorehabil Neural Repair. 2014 Oct;28(8):770-8. doi: 10.1177/1545968314522350. Epub 2014 Feb 13.
- Results publication: PubMed 31434543Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas G Hornby principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity training in variable contexts and Conventional balance training in people with Cerebellar Disorders and Cerebellar Degeneration, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas G Hornby (3123508291, tghornby@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-min walk test (time frame: Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07621978, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.