Exercise Training Program for Cerebellar Ataxia

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.

Study Overview

• Status: Completed
• Conditions: Cerebellar Ataxia
• Intervention / Treatment: Behavioral: Home exercise program

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: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Motion Analysis Lab in the Kennedy Krieger Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Motion Analysis Lab website at the Kennedy Krieger Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; training; ataxia; cerebellar
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Cerebellar Diseases; Ataxia; Cerebellar Ataxia
• Other Study ID Numbers: NA_00008601; 2R01HD040289-05A1 (U.S. NIH Grant/Contract)