Variable Intense Training for Ataxia and Locomotion

NCT07621978 | Not Yet Recruiting DMC

• 1 other identifier: IU31611
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cerebellar diseases, high-intensity training

Outcome Measures

Primary Outcomes (1)

• 6-min walk test

  Participants will walk for 6 minutes with instructions to "cover as much ground as they can".

  Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks

Study Arms (2)

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.

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.

Other: Conventional balance training

Interventions

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.

Also known as: Locomotor training at higher intensities

High-intensity training in variable contexts

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.

Also known as: Static and dynamic stability training

Conventional balance training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rehabilitation Hospital of Indiana: collaborator
• Indiana University: lead

Related Publications (2)

• 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.

  PMID: 24526707 BACKGROUND

• Hornby 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.

  PMID: 31434543 RESULT

MeSH Terms

Conditions

Cerebellar Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Thomas G Hornby

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas G Hornby

CONTACT

3123508291; tghornby@iu.edu

Christopher Henderson

CONTACT

3173292353; henderce@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be performed by blinded raters unaware of group assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, controlled cross-over trial

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share