Cerebellar AtaxiaNCT01307176
Exercise Training Program for Cerebellar Ataxia
A study testing Home exercise program in people with Cerebellar Ataxia, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- Home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2015
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebellar damage from stroke, tumor, or degeneration
- Able to stand and take steps with or without assistance
- Age 18-95
Who cannot join
- Extrapyramidal symptoms
- Peripheral vestibular loss (e.g. absence of VOR)
- Congestive heart failure
- Peripheral artery disease with claudication
- Pulmonary or Renal Failure
- Unstable angina
Show all 13Show fewer
- Uncontrolled hypertension ( > 190/100 mmHg)
- Dementia (Mini-Mental State exam > 22)
- Severe aphasia
- Orthopedic or pain conditions
- Pregnancy
- Prisoner
- Evidence of chronic white matter disease on MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Motion Analysis Lab in the Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
The purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises.
Read the detailed description
The cerebellum is important for coordination of movement and for motor learning. No medications systematically improve cerebellar ataxia, and little is known about the effectiveness of rehabilitation exercises, which are often the only treatment option. Here, we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. This pilot-clinical trial will test a subject's ability to adaptively learn a new walking pattern in a single session, and then any improvement of walking and balance over a 13 week time period during which they participate in a specialized home exercise training program. Our prediction is that those individuals with some preserved adaptive learning ability will be the best rehabilitation candidates.
- Conditions
- Cerebellar Ataxia
- Being tested
- Home exercise program
- Keywords
- ataxia, exercise, training, cerebellar, rehabilitation
- Medical subject headings
- Cerebellar Ataxia, Ataxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise programBehavioural
Also called Woodway Split Belt Treadmill, Company: Woodway USA, Inc
The home exercise program uses standard physical therapy exercises that have never been rigorously tested for people with cerebellar ataxia. These include sitting balance exercises (e.g. sitting on a peanut-shaped exercise ball and moving arms or legs), standing balance exercises (e.g. weight shifting, moving arms and legs), and walking exercises (e.g. walking heel-to-toe). The exercises are in a progression, going from less to more challenging. Though the exercises are standard, they are the intervention that we are testing and we will consider them experimental.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise program | Experimental | Balance and walking exercise program Receives: Behavioral: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking speed from baseline to mid-training and to post-training
Here, we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. Our prediction is that those individuals with some preserved adaptive ability will be show the greatest improvement in walking speed.
Measured: Participants are assessed at baseline (week 1 and week 3), mid-training (week 6), and post-training (week 9 and week 13). There are a total of 13 weeks for this study with 5 visits during that time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014
- Study completionFeb 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Amy J Bastian, PhD, PT, Principal investigator, Kennedy Krieger Institute and Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307176
- Sponsor's protocol ID
- NA_00008601
- Other IDs
- 2R01HD040289-05A1
- Status last verified
- Mar 2015
- First submitted
- 23 Feb 2011
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Program for Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT01307176
- Acronym / sponsor ID
- NA_00008601
- Conditions
- Cerebellar Ataxia
- Keywords
- ataxia, exercise, training, cerebellar, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Mar 2011 (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.
The purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises.
Detailed description
The cerebellum is important for coordination of movement and for motor learning. No medications systematically improve cerebellar ataxia, and little is known about the effectiveness of rehabilitation exercises, which are often the only treatment option. Here, we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. This pilot-clinical trial will test a subject's ability to adaptively learn a new walking pattern in a single session, and then any improvement of walking and balance over a 13 week time period during which they participate in a specialized home exercise training program. Our prediction is that those individuals with some preserved adaptive learning ability will be the best rehabilitation candidates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home exercise program | Experimental | Behavioral: Home exercise programBalance and walking exercise program |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cerebellar damage from stroke, tumor, or degeneration
- Able to stand and take steps with or without assistance
- Age 18-95
Key exclusion criteria (13 listed)
- Extrapyramidal symptoms
- Peripheral vestibular loss (e.g. absence of VOR)
- Congestive heart failure
- Peripheral artery disease with claudication
- Pulmonary or Renal Failure
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 |
|---|---|---|
| Home exercise programAlso: Woodway Split Belt Treadmill, Company: Woodway USA, IncThe home exercise program uses standard physical therapy exercises that have never been rigorously tested for people with cerebellar ataxia. These include sitting balance exercises (e.g. sitting on a peanut-shaped exercise ball and moving arms or legs), standing balance exercises (e.g. weight shifting, moving arms and legs), and walking exercises (e.g. walking heel-to-toe). The exercises are in a progression, going from less to more challenging. Though the exercises are standard, they are the intervention that we are testing and we will consider them experimental. | Behavioural | Home exercise program |
Primary outcome
Change in walking speed from baseline to mid-training and to post-training
Time frame: Participants are assessed at baseline (week 1 and week 3), mid-training (week 6), and post-training (week 9 and week 13). There are a total of 13 weeks for this study with 5 visits during that time period
Here, we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. Our prediction is that those individuals with some preserved adaptive ability will be show the greatest improvement in walking speed.
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 1 Apr 2015.
- Motion Analysis Lab website at the Kennedy Krieger InstituteLink provided by the sponsor.
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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.
Amy J Bastian, PhD, PT principal investigator
Kennedy Krieger Institute and Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise program in people with Cerebellar Ataxia, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 3 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 1 Apr 2015. 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 walking speed from baseline to mid-training and to post-training (time frame: Participants are assessed at baseline (week 1 and week 3), mid-training (week 6), and post-training (week 9 and week 13). There are a total of 13 weeks for this study with 5 visits during that time period). 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 1 Apr 2015.