Exercise Training Program for Cerebellar Ataxia

This study is ongoing, but not recruiting participants.

Sponsor:

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.

ClinicalTrials.gov Identifier:

NCT01307176

First received: February 23, 2011

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2011

Last Updated Date

February 6, 2013

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01307176 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Exercise Training Program for Cerebellar Ataxia

Official Title ^ICMJE

Exercise Training Program for Cerebellar Ataxia

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cerebellar Ataxia

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Home exercise program

Balance and walking exercise program

Intervention: Behavioral: Home exercise program

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01307176

Other Study ID Numbers ^ICMJE

NA_00008601, 2R01HD040289-05A1

Has Data Monitoring Committee

Responsible Party

Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Sponsor ^ICMJE

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborators ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators ^ICMJE

Principal Investigator:

Amy J Bastian, PhD, PT

Kennedy Krieger Institute and Johns Hopkins School of Medicine

Information Provided By

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Verification Date

February 2013

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

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