Back to resultsAugmenting Balance in Individuals With Cerebellar Ataxias
Primary Purpose
Cerebellar Ataxia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory Augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Cerebellar Ataxia focused on measuring ataxia, balance training, vibrotactile biofeedback, sensory augmentation, cerebellar ataxia
Eligibility Criteria
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
Sites / Locations
- Department of Mechanical Engineering, University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sensory Augmentation Group 1
Sensory Augmentation Group 2
Arm Description
Each subject in Group 1 will undergo 6 weeks of balance training with sensory augmentation followed by 6 weeks of balance training without sensory augmentation.
Each subject in Group 2 will undergo 6 weeks of balance training without sensory augmentation followed by 6 weeks of balance training with sensory augmentation.
Outcomes
Primary Outcome Measures
Change in Scale for the assessment and rating of ataxia (SARA)
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.
Secondary Outcome Measures
Change in 10-meter Preferred Gait Speed
Preferred gait velocity will be measured while walking a 10-meter path.
Change in 10-meter Fast Gait Speed
Fast gait velocity will be measured while walking a 10-meter path.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02887703
Brief Title
Augmenting Balance in Individuals With Cerebellar Ataxias
Official Title
Augmenting Balance in Individuals With Cerebellar Ataxias
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathleen Sienko
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia
Keywords
ataxia, balance training, vibrotactile biofeedback, sensory augmentation, cerebellar ataxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensory Augmentation Group 1
Arm Type
Experimental
Arm Description
Each subject in Group 1 will undergo 6 weeks of balance training with sensory augmentation followed by 6 weeks of balance training without sensory augmentation.
Arm Title
Sensory Augmentation Group 2
Arm Type
Experimental
Arm Description
Each subject in Group 2 will undergo 6 weeks of balance training without sensory augmentation followed by 6 weeks of balance training with sensory augmentation.
Intervention Type
Behavioral
Intervention Name(s)
Sensory Augmentation
Other Intervention Name(s)
vibrotactile biofeedback, haptic feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Scale for the assessment and rating of ataxia (SARA)
Description
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.
Time Frame
pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Secondary Outcome Measure Information:
Title
Change in 10-meter Preferred Gait Speed
Description
Preferred gait velocity will be measured while walking a 10-meter path.
Time Frame
pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Title
Change in 10-meter Fast Gait Speed
Description
Fast gait velocity will be measured while walking a 10-meter path.
Time Frame
pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Other Pre-specified Outcome Measures:
Title
Change in Five Times Sit to Stand Test
Description
A stop watch is used to measure how long it takes a participant to stand up and sit down five times in a row without using their hands.
Time Frame
pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Title
Change in Activities Specific Balance scale (ABC)
Description
A 16-item questionnaire for participants to self report their balance confidence during activities of daily living.
Time Frame
pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Title
Change in Berg Balance Score
Description
A 14-item scale to assess balance including sit-to-stand, standing, turning and picking up items from the floor.
Time Frame
pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Title
Change in Dynamic Gait Index (DGI)
Description
An 8-item test to evaluate gait function including normal and fast walking, changing speeds, stepping over obstacles, pivoting, walking with head turns, and stairs.
Time Frame
pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen H Sienko, Ph.D.
Organizational Affiliation
Department of Mechanical Engineering
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Mechanical Engineering, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Augmenting Balance in Individuals With Cerebellar Ataxias
We'll reach out to this number within 24 hrs