Exercise Training Program for Cerebellar Ataxia

This study is ongoing, but not recruiting participants.
Sponsor:
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

February 23, 2011
February 6, 2013
February 2011
February 2014   (final data collection date for 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01307176 on ClinicalTrials.gov Archive Site
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Exercise Training Program for Cerebellar Ataxia
Exercise Training Program for Cerebellar Ataxia

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebellar Ataxia
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
Experimental: Home exercise program
Balance and walking exercise program
Intervention: Behavioral: Home exercise program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
February 2015
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01307176
NA_00008601, 2R01HD040289-05A1
No
Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Amy J Bastian, PhD, PT Kennedy Krieger Institute and Johns Hopkins School of Medicine
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP