Augmenting Balance in Individuals With Cerebellar Ataxias
Completed · Not applicable
Conditions studied: Cerebellar Ataxia
In brief
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.
Key facts
- Study ID
- NCT02887703
- Run by
- Kathleen Sienko
- People needed
- 10
- Starts
- 2016-09-01
- Expected to finish
- 2018-01-31
- Last updated by the study team
- 2018-03-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Report to be in good general health
- Are able to read and comprehend English
- Have been diagnosed with either an inherited or sporadic degenerative cerebellar or sensory ataxia
- Are able to stand for at least 30 seconds with no support
- Must be willing and able to comply with study schedule
- Must have wireless internet (WiFi) enabled in their home
- Must be able to perform the home based exercises safely (as assessed by clinical research staff)
You may not qualify if…
- Are pregnant or believe subject might be pregnant
- Have been diagnosed with arthritis or other musculoskeletal disorder affecting joints, muscles, ligaments and/or nerves that affects the way subject moves
- Have a history of fainting
- Have a severe vision or hearing impairment that is not corrected by glasses or hearing aids
- Have sustained a fall in the last six months that resulted in hospitalization or serious injury
- Have corrected vision worse than 20/70 (considered threshold for moderate visual impairment)
- Are unable to feel the vibrotactile feedback on their torso through the standard t-shirt provided by the study team
- Have ankle dorsi-flexor/plantar-flexor weakness as demonstrated < 4/5 on manual muscle test
- Have limited ankle range of motion demonstrated by inability to dorsiflex to neutral with the knee extended
- Report lower extremity fracture/sprain in the past six months or more than one lower extremity total joint replacement
- Are medically unstable (e.g. chest pain upon exertion, dyspnea, infection)
- Have a history of any other neurological disease besides ataxia that might affect balance (e.g. cerebral vascular accident, Parkinson's disease, MS, ataxia)
- Have a body mass index (BMI) over 30 kg/m2, computed from subject height and weight
Where it is running
- Department of Mechanical Engineering, University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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