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Long Term Split Belt Treadmill Training for Stroke Recovery

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ClinicalTrials.gov Identifier: NCT01646216
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Maryland
VA Office of Research and Development
Information provided by (Responsible Party):
Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Split belt treadmill
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Split Belt Treadmill Training for Stroke Recovery
Actual Study Start Date : June 7, 2012
Actual Primary Completion Date : February 24, 2017
Actual Study Completion Date : September 30, 2017

Arm Intervention/treatment
Experimental: Split-belt treadmill training
Split-belt treadmill exercise
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




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: After training (week 14), 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: Post training (week 14), and 3 months follow up ]
    This is the change in metabolic power that is required of a subject to walk at their self selected walking speed on the treadmill. Metabolic power was measured at baseline, post training, and three months after training. We report the difference between post training and baseline and three months and baseline.

  2. Walking Speed [ Time Frame: Baseline, post training, and 3 month follow up. ]
    Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.



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

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

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


Locations
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
Investigators
Principal Investigator: Amy J Bastian, PhD, PT Kennedy Krieger Institute and Johns Hopkins School of Medicine
  Study Documents (Full-Text)

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

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
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018
Last Verified: February 2018

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

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