Locomotor Training for Neurological Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01288040
First received: January 25, 2011
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Hemiparesis
Behavioral: Split Belt treadmill
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Locomotor Training for Neurological Disease

Resource links provided by NLM:


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

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


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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 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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01288040

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.
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., Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01288040     History of Changes
Other Study ID Numbers: NA_00010292, 1R01HD048741
Study First Received: January 25, 2011
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014