Clinical Trial: Augmenting Balance in Individuals With Cerebellar Ataxias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Augmenting Balance in Individuals With Cerebellar Ataxias

Brief Summary: This study evaluates the effectiveness of a 12-week in home balance training program with and without sensory augmentation for individuals with ataxia. Subjects wear a belt while performing balance exercises three times per week for 12 weeks. The belt measures body motion and has small vibrating elements called tactors mounted inside that when turned on, feel like a cell phone set to vibrate. The tactors provide information about body motion and indicate when and how to make a postural correction. Subjects will receive six weeks of balance training with the tactors turned on and six weeks of balance training with the tactors turned off.

Detailed Summary: Cerebellar ataxias are a group of degenerative neurological disorders, resulting in deficits in speech, limb control, balance, and gait. Individuals with degenerative cerebellar ataxias are at a high-risk of falling and have progressive impairments in motor coordination resulting in unsteadiness in gait and posture. No definitive treatment options are available for ataxia. There is therefore a critical need to identify strategies to improve motor function and reduce falls in patients with ataxia. Physical therapy has been demonstrated to improve motor function in subjects with cerebellar ataxia, but the gains in performance following balance training are modest. Sensory augmentation is a technique of augmenting or replacing compromised sensory information. In the context of sensory-based balance impairments, a sensory augmentation device provides cues of body motion that supplement an individual's remaining intact sensory systems. The investigators hypothesize that sensory augmentation may improve the effectiveness of balance training in individuals with ataxia, and aid in greater improvement in motor function than traditional physical therapy alone. Sensory augmentation has been shown to decrease body sway during real-time operation in a laboratory setting in individuals with vestibular deficits and peripheral neuropathy, and general age-related declines in balance performance. Preliminary results suggest that persistent improvements in balance performance exist over time periods of hours to days following a small number of training sessions. This study aims to characterize the effects of sensory augmentation in individuals with ataxia during static and dynamic balance exercises over a period of twelve weeks of in home balance training with and without vibrotactile sensory augmentation.
Sponsor: Kathleen Sienko

Current Primary Outcome: Change in Scale for the assessment and rating of ataxia (SARA) [ Time Frame: pre balance training (week 1), mid balance training (week 6), post balance training (week 12) ]

An 8-item scale including walking, standing, sitting, nose-to-finger movements, and fast alternating movements. Standard assessment scale for determining impairment level in individuals with ataxia.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in 10-meter Preferred Gait Speed [ Time Frame: pre balance training (week 1), mid balance training (week 6), post balance training (week 12) ]
    Preferred gait velocity will be measured while walking a 10-meter path.
  • Change in 10-meter Fast Gait Speed [ Time Frame: pre balance training (week 1), mid balance training (week 6), post balance training (week 12) ]
    Fast gait velocity will be measured while walking a 10-meter path.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: August 22, 2016
Date Started: September 2016
Date Completion: December 1, 2017
Last Updated: April 25, 2017
Last Verified: April 2017