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RecruitingNCT07621978ClinicalTrials.gov record

Variable Intense Training for Ataxia and Locomotion

Cerebellar Disorders · Cerebellar Degeneration · Cerebellar Atrophy · Cerebellar Lesions

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 85 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
20 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Single masked
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.

Other: High-intensity training in variable contexts

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.

Other: Conventional balance training

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.

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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".

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Rehabilitation Hospital of IndianaIndianapolis, Indiana, United StatesRecruiting

Study team and timeline

Lead sponsor
Indiana University
Study start
Jun 15, 2026 Actual
Primary completion
Jun 15, 2028 Estimated
Study completion
Dec 15, 2028 Estimated
First posted
Jun 2, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Thomas G HornbyCONTACTtghornby@iu.edu3123508291
Christopher HendersonCONTACThenderce@iu.edu3173292353
Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026