Locomotor Training for Neurological Disease

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT01288040

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Location

Arm

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 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, 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 Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Locomotor Training for Neurological Disease

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

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 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

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

Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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