Trial record 3 of 364 for:    Stroke | Open Studies | NIH, U.S. Fed

Long Term Split Belt Treadmill Training for Stroke Recovery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Collaborators:
University of Maryland, Baltimore County
Information provided by (Responsible Party):
Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01646216
First received: April 5, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Stroke
Hemiparesis
Behavioral: Split belt treadmill
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Split Belt Treadmill Training for Stroke Recovery

Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Walking speed [ Time Frame: Before training, periodically during training, post training and 1- and 3 months after training ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 14
Study Start Date: June 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646216

Contacts
Contact: Katharine E Amenabar, MS 443-923-2716 amenabar@kennedykrieger.org

Locations
United States, Maryland
Motion Analysis Lab in the Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Katharine E Amenabar, MS    443-923-2716    amenabar@kennedykrieger.org   
Principal Investigator: Amy J Bastian, PhD, PT         
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
University of Maryland, Baltimore County
Investigators
Principal Investigator: Amy J Bastian, PhD, PT Kennedy Krieger Institute and Johns Hopkins School of Medicine
  More Information

Additional Information:
No publications provided

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
Study First Received: April 5, 2012
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014