Exercise Training Program for Cerebellar Ataxia

NCT ID: NCT01307176

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-02-28

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.

Conditions

Cerebellar Ataxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home exercise program

Balance and walking exercise program

Group Type: EXPERIMENTAL

Home exercise program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Woodway Split Belt Treadmill; Company: Woodway USA, Inc

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Amy J. Bastian, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy J Bastian, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Kennedy Krieger Institute and Johns Hopkins School of Medicine

Locations

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Related Links

http://www.kennedykrieger.org/kki_research.jsp?pid=5741

Motion Analysis Lab website at the Kennedy Krieger Institute

Other Identifiers

2R01HD040289-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00008601

Identifier Type: -

Identifier Source: org_study_id