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
  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:


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:
  • 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014