Exercise Training Program for Cerebellar Ataxia

NCT01307176 | Completed

• 2 other identifiers: NA_000086012R01HD040289-05A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebellar Ataxia

Keywords

ataxia; exercise; training; cerebellar; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (1)

Home exercise program

EXPERIMENTAL

Balance and walking exercise program

Behavioral: Home exercise program

Interventions

Home exercise program 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.

Also known as: Woodway Split Belt Treadmill, Company: Woodway USA, Inc

Home exercise program

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cerebellar damage from stroke, tumor, or degeneration
• Able to stand and take steps with or without assistance
• Age 18-95

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Links

• Motion Analysis Lab website at the Kennedy Krieger Institute

MeSH Terms

Conditions

Cerebellar Ataxia; Ataxia; Motor Activity

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Amy J Bastian, PhD, PT

  Kennedy Krieger Institute and Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: March 2, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (1)