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Variable Intense Training for Ataxia and Locomotion

Feasibility and Potential Efficacy of High-intensity Gait Training in Individuals With Cerebellar Damage

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07621978
Acronym
VITAL
Enrollment
20
Registered
2026-06-02
Start date
2026-06-15
Completion date
2028-12-15
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Atrophy, Cerebellar Degeneration, Cerebellar Disorders, Cerebellar Lesions

Keywords

Cerebellar diseases, high-intensity training

Brief 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

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

Interventions

OTHERHigh-intensity training in variable contexts

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 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.

Sponsors

Indiana University
Lead SponsorOTHER
Rehabilitation Hospital of Indiana
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessments will be performed by blinded raters unaware of group assignment.

Intervention model description

Randomized, controlled cross-over trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
6-min walk testChanges from baseline to post-training following up to 20 sessions over approximately 8 weeksParticipants will walk for 6 minutes with instructions to "cover as much ground as they can".

Contacts

CONTACTThomas G Hornby
tghornby@iu.edu3123508291
CONTACTChristopher Henderson
henderce@iu.edu3173292353
PRINCIPAL_INVESTIGATORThomas G Hornby

Indiana University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026