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Locomotor Training for Neurological Disease

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Phase 1
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

2 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Motion Analysis Lab in the Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treadmill exercise

Arm Description

Split-belt treadmill training

Outcomes

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
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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2011
Last Updated
March 31, 2015
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01288040
Brief Title
Locomotor Training for Neurological Disease
Official Title
Locomotor Training for Neurological Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

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
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill exercise
Arm Type
Experimental
Arm Description
Split-belt treadmill training
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 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.
Primary Outcome Measure Information:
Title
Whether different schedules and types of long term training on a custom split belt treadmill are likely to change/improve walking symmetry
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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
Motion Analysis Lab website at the Kennedy Krieger Institute

Learn more about this trial

Locomotor Training for Neurological Disease

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