Exercise Training Program for Cerebellar Ataxia
This study is ongoing, but not recruiting participants.
Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator:
Information provided by (Responsible Party):
Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01307176
First received: February 23, 2011
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebellar Ataxia |
Behavioral: Home exercise program |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Exercise Training Program for Cerebellar Ataxia |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal recessive cerebellar ataxia type 1
VLDLR-associated cerebellar hypoplasia
MedlinePlus related topics:
Exercise and Physical Fitness
U.S. FDA Resources
Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 36 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Home exercise program
Balance and walking exercise program
|
Behavioral: Home exercise program
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.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cerebellar damage from stroke, tumor, or degeneration
- Able to stand and take steps with or without assistance
- Age 18-95
Exclusion Criteria:
- Extrapyramidal symptoms
- Peripheral vestibular loss (e.g. absence of VOR)
- Congestive heart failure
- Peripheral artery disease with claudication
- Pulmonary or Renal Failure
- Unstable angina
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307176
Locations
| United States, Maryland | |
| Motion Analysis Lab in the Kennedy Krieger Institute | |
| Baltimore, Maryland, United States, 21205 | |
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
| Principal Investigator: | Amy J Bastian, PhD, PT | Kennedy Krieger Institute and Johns Hopkins School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amy J. Bastian, Ph.D., Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| ClinicalTrials.gov Identifier: | NCT01307176 History of Changes |
| Other Study ID Numbers: | NA_00008601, 2R01HD040289-05A1 |
| Study First Received: | February 23, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
|
ataxia exercise training cerebellar rehabilitation |
Additional relevant MeSH terms:
|
Ataxia Cerebellar Ataxia Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Cerebellar Diseases Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013