Recruiting

High-Intensity Training

Sponsor:

Indiana University

Code:

NCT07621978

Conditions

Cerebellar Disorders

Cerebellar Degeneration

Cerebellar Atrophy

Cerebellar Lesions

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

High-intensity training in variable contexts

Conventional balance training

Study Details

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

Conditions

Cerebellar Disorders

Cerebellar Degeneration

Cerebellar Atrophy

Cerebellar Lesions

Study ID

NCT07621978

Start date

Jun 15, 2026

Status verified date

May, 2026

Completion date

Dec 15, 2028

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High-intensity training in variable contexts

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.

active comparator: Conventional balance training

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.

Interventions

High-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 balance 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.

Primary outcome measure

  • 6-min walk test [ Time Frame: Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks ]

Central Contacts and Locations

Central contacts

Thomas G Hornby

3123508291tghornby@iu.edu

Christopher Henderson

3173292353henderce@iu.edu

Locations

Rehabilitation Hospital of Indiana

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

Thomas Hornby

3123508291tghornby@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Nov 10, 2026

Last verified

May, 2026

Keywords

  • Cerebellar diseases, high-intensity training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Indiana University on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.