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Long Term Split Belt Treadmill Training for Stroke Recovery

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ClinicalTrials.gov Identifier: NCT01646216
Recruitment Status : Active, not recruiting
First Posted : July 20, 2012
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether split belt or conventional treadmill training can be used to treat walking pattern deficits from stroke and to determine whether this improves gait asymmetry and metabolic efficiency.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Behavioral: Split belt treadmill Phase 1

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. 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 or up to 4 week 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 types of treadmill training on a custom split-belt treadmill are likely to change/improve walking symmetry as well as metabolic efficiency.

The investigators will study adults with cerebral damage due to stroke. Subjects with hemiparesis will undergo training 3 times a week for a total of 33 training session. These 33 sessions will be broken into 3 blocks of 11 sessions. After each block of 11 sessions an evaluation will be done to record any gait improvements. Training for the subjects with hemiparesis will either be conventional treadmill walking (both legs moving at the same speed) or split-belt treadmill walking (with one leg moving faster than the other). 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 as well as to determine whether this training can influence the subject's body's ability to use its intake of oxygen more efficiently. 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Split Belt Treadmill Training for Stroke Recovery
Study Start Date : June 2012
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017
Arms and Interventions

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 move 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 or slightly different speeds.
Other Names:
  • Woodway Split Belt Treadmill
  • Company: Woodway USA, Inc

Outcome Measures

Primary Outcome Measures :
  1. Change in Baseline Step length symmetry. That is, whether the steps with right and left legs are the same length. [ Time Frame: Baseline Visit 1 (week 1) and Baseline Visit 2 (week 2), 2 times during training (once at week 6 and once at week 10), after training (week 14), and 1- and 3 months after training ]
    Subjects will either walk on a special mat that records their step lengths, or will wear special markers on the feet and body to record their step lengths.

Secondary Outcome Measures :
  1. Change in Baseline Oxygen intake [ Time Frame: Baseline Visit 1 (week 1) and Baseline Visit 2 (week 2), 2 times during training (once at week 6 and once at week 10), after training (week 14), and 1- and 3 months after training ]
    A metabolic cart will be used while the subject is walking on the treadmill to determine if training is helping their bodies become more efficient with their oxygen intake.

  2. Walking speed [ Time Frame: Before training, periodically during training, post training and 1- and 3 months after training ]
    Subjects will complete a 6 meter walking test to determine if the treadmill training has increased their walking speed. This will allow for a progressive increase in treadmill speed during training for each individual subject.

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • stroke or hemiparesis (>6 months post stroke)
  • 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
  • Adults age 20-80

Exclusion Criteria:

  • Cerebellar signs (e.g.ataxic hemiparesis)
  • Any neurologic condition other than stroke
  • Insulin dependent diabetes
  • 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 that limit walking
  • Total joint replacement in the lower extremities
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646216

United States, Maryland
Motion Analysis Lab in the Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Maryland
VA Office of Research and Development
Principal Investigator: Amy J Bastian, PhD, PT Kennedy Krieger Institute and Johns Hopkins School of Medicine
More Information

Additional Information:
Responsible Party: Amy J. Bastian, Ph.D., Dr. Amy J Bastian, Ph.D., PT, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01646216     History of Changes
Other Study ID Numbers: NA_00068967
2P30AG028747-06 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms