Cerebellar AtaxiaNCT02887703
Augmenting Balance in Individuals With Cerebellar Ataxias
A study testing Sensory Augmentation in people with Cerebellar Ataxia, run by Kathleen Sienko at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- Sensory Augmentation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Mechanical Engineering, University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Cerebellar Ataxia
- Being tested
- Sensory Augmentation
- Keywords
- ataxia, balance training, vibrotactile biofeedback, sensory augmentation, cerebellar ataxia
- Medical subject headings
- Cerebellar Ataxia, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory AugmentationBehavioural
Also called vibrotactile biofeedback, haptic feedback
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.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Augmentation Group 1 | Experimental | 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. Receives: Behavioral: Sensory Augmentation |
| Sensory Augmentation Group 2 | Experimental | 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. Receives: Behavioral: Sensory Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Secondary outcomes (2)
Change in 10-meter Preferred Gait Speed
Preferred gait velocity will be measured while walking a 10-meter path.
Measured: pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Change in 10-meter Fast Gait Speed
Fast gait velocity will be measured while walking a 10-meter path.
Measured: pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen Sienko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathleen Sienko, University of Michigan
- Investigators
- Kathleen H Sienko, Ph.D., Principal investigator, Department of Mechanical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887703
- Sponsor's protocol ID
- HUM00116756
- Status last verified
- Mar 2018
- First submitted
- 22 Aug 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Balance in Individuals With Cerebellar Ataxias
- ClinicalTrials.gov ID
- NCT02887703
- Acronym / sponsor ID
- HUM00116756
- Conditions
- Cerebellar Ataxia
- Keywords
- ataxia, balance training, vibrotactile biofeedback, sensory augmentation, cerebellar ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kathleen SienkoUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Augmentation Group 1 | Experimental | Behavioral: Sensory AugmentationEach subject in Group 1 will undergo 6 weeks of balance training with sensory augmentation followed by 6 weeks of balance training without sensory augmentation. |
| Sensory Augmentation Group 2 | Experimental | Behavioral: Sensory AugmentationEach subject in Group 2 will undergo 6 weeks of balance training without sensory augmentation followed by 6 weeks of balance training with sensory augmentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory AugmentationAlso: vibrotactile biofeedback, haptic feedbackSensory 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. | Behavioural | Sensory Augmentation Group 1, Sensory Augmentation Group 2 |
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.
2 secondary outcomes
Change in 10-meter Preferred Gait Speed
Time frame: pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Change in 10-meter Fast Gait Speed
Time frame: pre balance training (week 1), mid balance training (week 6), post balance training (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebellar Ataxia
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Friedreich Ataxia
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
Recruiting
Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.
Friedreich's Ataxia, Motor Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen H Sienko, Ph.D. principal investigator
Department of Mechanical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Augmentation in people with Cerebellar Ataxia, run by Kathleen Sienko at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.