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Exercise Training Program for Cerebellar Ataxia

Primary Purpose

Cerebellar Ataxia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home exercise program
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Ataxia focused on measuring ataxia, exercise, training, cerebellar, rehabilitation

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Motion Analysis Lab in the Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home exercise program

Arm Description

Balance and walking exercise program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2011
Last Updated
March 31, 2015
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01307176
Brief Title
Exercise Training Program for Cerebellar Ataxia
Official Title
Exercise Training Program for Cerebellar Ataxia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia
Keywords
ataxia, exercise, training, cerebellar, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home exercise program
Arm Type
Experimental
Arm Description
Balance and walking exercise program
Intervention Type
Behavioral
Intervention Name(s)
Home exercise program
Other Intervention Name(s)
Woodway Split Belt Treadmill, Company: Woodway USA, Inc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in walking speed from baseline to mid-training and to post-training
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy J Bastian, PhD, PT
Organizational Affiliation
Kennedy Krieger Institute and Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Analysis Lab in the Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.kennedykrieger.org/kki_research.jsp?pid=5741
Description
Motion Analysis Lab website at the Kennedy Krieger Institute

Learn more about this trial

Exercise Training Program for Cerebellar Ataxia

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