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Understanding Different Parameters in Locomotor Training (a Type of Walking Training) for Person After a Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00712179
First received: July 3, 2008
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
This is a research study to understand how people who have experienced a stroke walk in order to develop better and more effective types of therapy. Data collected from people who have experienced a stroke and healthy individuals will be used to compare a neurologically healthy person to someone, which has sustained an injury.

Condition
Stroke

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Developing Evidence-based Parameter Selection for Locomotor Training

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Diagnostic [ Time Frame: During sessions- 1 day measurement ] [ Designated as safety issue: No ]
    The electromyographic (EMG) gait pattern of stroke survivors was compared with "normal" pattern using z-scores.


Enrollment: 49
Study Start Date: July 2008
Study Completion Date: December 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke Survivors
Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Controls and persons who have sustained a stroke
Criteria

Inclusion Criteria:

  • adults at least 18 years old;
  • able to provide informed consent;
  • able to follow three-step motor command;
  • have a single unilateral stroke;
  • medically stable (i.e. asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with walking;
  • able to stand with assistance and/or ambulate 15 meters with or without an assistive device or brace and no greater than standby physical assistance.

Exclusion Criteria:

  • weight > 300 pounds due to limitations in body weight support systems;
  • body size which is incompatible with harnesses;
  • pregnancy;
  • presence of significant musculoskeletal problems that limit hip and knee extension or ankle plantarflexion to neutral;
  • self selected walking speed below 0.3 m/s; and
  • history of congestive cardiac failure, unstable angina, or peripheral vascular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712179

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Steve A. Kautz, PhD MS BS Ralph H. Johnson VA Medical Center, Charleston, SC
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00712179     History of Changes
Other Study ID Numbers: A6365-R 
Study First Received: July 3, 2008
Results First Received: March 9, 2016
Last Updated: April 7, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Stroke
walking
Treadmill
body weight support system

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2016