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Long Term Split Belt Treadmill Training for Stroke Recovery

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Split belt treadmill
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, treadmill, walking, hemiparesis, training

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Motion Analysis Lab in the Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Split-belt treadmill training

Arm Description

Split-belt treadmill exercise

Outcomes

Primary Outcome Measures

Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.
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
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
Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.

Full Information

First Posted
April 5, 2012
Last Updated
January 10, 2019
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA), University of Maryland, VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01646216
Brief Title
Long Term Split Belt Treadmill Training for Stroke Recovery
Official Title
Long Term Split Belt Treadmill Training for Stroke Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 7, 2012 (Actual)
Primary Completion Date
February 24, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA), University of Maryland, VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
stroke, treadmill, walking, hemiparesis, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split belt treadmill
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Split-belt treadmill training
Arm Type
Experimental
Arm Description
Split-belt treadmill exercise
Intervention Type
Behavioral
Intervention Name(s)
Split belt treadmill
Other Intervention Name(s)
Woodway Split Belt Treadmill, Company: Woodway USA, Inc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.
Description
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.
Time Frame
After training (week 14), and 3 months after training
Secondary Outcome Measure Information:
Title
Change in Baseline Oxygen Intake
Description
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.
Time Frame
Post training (week 14), and 3 months follow up
Title
Walking Speed
Description
Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.
Time Frame
Baseline, post training, and 3 month follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy J Bastian, PhD, PT
Organizational Affiliation
Kennedy Krieger Institute and Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Analysis Lab in the Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.kennedykrieger.org/kki_research.jsp?pid=5741
Description
Link Text: Motion Analysis Lab website at the Kennedy Krieger Institute

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Long Term Split Belt Treadmill Training for Stroke Recovery

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