Augmenting Balance in Individuals With Cerebellar Ataxias
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | September 2016 |
| End Date: | January 31, 2018 |
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.
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.
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
1
site
2350 Hayward Street
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Phone: 734-647-8249
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