Clinical trial NCT01288040: Locomotor Training for Neurological Disease
Official title: Locomotor Training for Neurological Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Hemiparesis
Keywords: stroke
treadmill
walking
hemiparesis
training
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-02-02
Enrollment: 92
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Whether different schedules and types of long term training on a custom split belt treadmill are likely to change/improve walking symmetry
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Motion Analysis Lab in the Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Kennedy Krieger Institute and Johns Hopkins School of Medicine
name: Amy J Bastian, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: