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NCT Number: NCT07621978

Variable Intense Training for Ataxia and Locomotion

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

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Key information

Conditions

Cerebellar Disorders Brain Diseases Central Nervous System Diseases Cerebellar Atrophy Cerebellar Degeneration Cerebellar Diseases Cerebellar Lesions Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity training in variable contexts

Other

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.

Other names: Locomotor training at higher intensities

Conventional balance training

Other

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.

Other names: Static and dynamic stability training

Primary outcomes

  1. 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Henderson

CONTACT

[email protected]

3173292353

Thomas G Hornby

CONTACT

[email protected]

3123508291

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Rehabilitation Hospital of Indiana

Registry information

Official study title

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

Acronym: VITAL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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