Exercise Training Program for Cerebella… | Clinical Trial

Key information

Conditions

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

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Woodway Split Belt Treadmill, Company: Woodway USA, Inc

Primary outcomes

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

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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Mar 2, 2011
Registry last updated: Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed