Locomotor Training for Neurological Disease

March 31, 2015 updated by: Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
The purpose of this study is to determine whether split belt training can be used to treat walking pattern deficits from stroke and to determine whether different schedules and types of long term training on a custom split belt treadmill are likely to change/improve walking symmetry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coordination between the legs during walking is often disrupted after neurological injury, resulting in asymmetric gait patterns. Recent data shows that walking patterns can be altered through treadmill training, even after central nervous system damage. The investigators have studied short-term adaptation of inter-limb coordination during walking using a split-belt treadmill to control speed of the two legs independently. Our findings demonstrate that walking patterns are adaptable, and that this process is dependent on cerebellar integrity. The investigators have also shown that people with cerebral damage from stroke can benefit in the short-term to correct asymmetric walking patterns. Since all of our previous work has focused on single training sessions, the investigators would like to study long-term effects of split belt treadmill training. Therefore, the purpose of this study is to prepare for a clinical trial of split-belt treadmill training to treat walking pattern deficits from cerebral damage. The investigators will gather data to determine whether different schedules and types of long-term training on a custom split-belt treadmill are likely to change/improve walking symmetry.

The investigators will study subjects with and without cerebral damage. Subjects without hemiparesis will simply be trained daily for 2 weeks to understand how they learn a new pattern on the treadmill for comparison with patients. Subjects with hemiparesis will undergo training daily for 2 weeks or the same dose of training, spread over 4 weeks. Training for the subjects with hemiparesis will either be conventional treadmill walking or split-belt treadmill walking with one leg moving faster than the other. The investigators will study children and adults with hemiparesis. These studies will provide important new information about normal mechanisms of locomotor adaptation, as well as providing a new rehabilitation tool for people with asymmetric gait patterns. Note that this study is not an aerobic conditioning program since subjects will work well below their age-adjusted target heart rate; it is instead a retraining program aimed at teaching people a new inter-limb coordination pattern. This study is also critical for developing procedural reliability processes, calculating effect sizes, training clinical staff, and determining other salient clinical variables in preparation for a randomized clinical trial.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stroke or hemiparesis
  • able to walk but has residual gait deficit (including those who walk with a cane or walker
  • This is their first and only stroke
  • Able to walk for 5 minutes at their self-paced speed
  • Children age 2-17; Adults age 18-80

Exclusion Criteria:

  • Cerebellar signs (e.g.ataxic hemiparesis)
  • Congestive heart failure
  • Peripheral artery disease with claudication
  • Pulmonary or renal failure
  • Unstable angina
  • Uncontrolled hypertension (>190/110 mmHg)
  • Dementia
  • Severe aphasia
  • Orthopedic or pain conditions
  • Foster children
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treadmill exercise
Split-belt treadmill training
Behavioral: Split Belt treadmill
A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to get at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same speed or both going slightly different speeds.
Other Names:
  • Woodway Split Belt Treadmill
  • Company: Woodway USA, Inc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whether different schedules and types of long term training on a custom split belt treadmill are likely to change/improve walking symmetry
Time Frame: Participants will be assessed at the beginning and end of either a 2 week or 4 week training schedule. All participants will be tested 1 month following the end of training.
To determine which schedule is showing more improvement different walking parameters will be investigated such as change in step length. Subjects will have markers placed at different joints on their body to allow our cameras to watch how their walking pattern changes during the duration of the study, to see if any improvements develop.
Participants will be assessed at the beginning and end of either a 2 week or 4 week training schedule. All participants will be tested 1 month following the end of training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (ESTIMATE)

February 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00010292
  • 1R01HD048741 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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