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Exercise Training Program for Cerebellar Ataxia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307176
First Posted: March 2, 2011
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training Program for Cerebellar Ataxia

Resource links provided by NLM:


Further study details as provided by Amy J. Bastian, Ph.D., 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 ]
    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.


Enrollment: 25
Study Start Date: February 2011
Study Completion Date: February 2015
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:
  • Woodway Split Belt Treadmill
  • Company: Woodway USA, Inc

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Amy J Bastian, PhD, PT Kennedy Krieger Institute and Johns Hopkins School of Medicine
  More Information

Additional Information:
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 ( U.S. NIH Grant/Contract )
First Submitted: February 23, 2011
First Posted: March 2, 2011
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Amy J. Bastian, Ph.D., 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