Exercise Training Program for Cerebellar Ataxia

Cerebellar Ataxia Clinical Trial

Official title:

Exercise Training Program for Cerebellar Ataxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307176
• Other study ID #: NA_00008601
• Secondary ID: 2R01HD040289-05A
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: March 31, 2015
• Start date: February 2011
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia

Intervention

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.

Locations

Country	Name	City	State
United States	Motion Analysis Lab in the Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Motion Analysis Lab website at the Kennedy Krieger Institute