Exercise Training Program for Cerebellar Ataxia

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT01307176
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
25
1
1
48
0.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Home exercise program
N/A

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

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Exercise Training Program for Cerebellar Ataxia
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in walking speed from baseline to mid-training and to post-training [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amy J. Bastian, Ph.D., Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    ClinicalTrials.gov Identifier:
    NCT01307176
    Other Study ID Numbers:
    • NA_00008601
    • 2R01HD040289-05A1
    First Posted:
    Mar 2, 2011
    Last Update Posted:
    Apr 1, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Amy J. Bastian, Ph.D., Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2015