Variable Intense Training for Ataxia and Locomotion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIndiana University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
High-intensity training in variable contexts
Other interventionHigh 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 interventionConventional 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: High-intensity training in variable contextsExperimental treatment 1 intervention
Group B: Conventional balance trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
6-min walk test
Participants will walk for 6 minutes with instructions to "cover as much ground as they can".
Time frame
Changes from baseline to post-training following up to 20 sessions over approximately 8 weeksLocations
Sponsors and contacts
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Indiana University
Lead sponsor
Rehabilitation Hospital of Indiana
Collaborator
Source ClinicalTrials.gov
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