Long Term Split Belt Treadmill Training for Stroke Recovery

Not Applicable

Completed

Conditions: Stroke
Hemiparesis

Interventions: Behavioral: Split belt treadmill

Registration Number: NCT01646216

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Split-belt treadmill training	Split belt treadmill	Split-belt treadmill exercise

Primary Outcome Measures

Name	Time	Method
Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.	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

Name	Time	Method
Change in Baseline Oxygen Intake	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.
Walking Speed	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.