Locomotor Training (Walking Therapy) Post Stroke

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00715299
First received: July 10, 2008
Last updated: May 9, 2011
Last verified: March 2011
  Purpose

This is a research study to examine a new type of walking therapy for people after they have had a stroke. We will study how people move and how their muscles work to see how the therapy helps people to walk better and to see how the therapy can be improved.


Condition Intervention
Stroke
Behavioral: locomotor training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanisms of Response to Locomotor Training After Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Spatiotemporal parameters of walking (including self selected and fastest safe walking speeds), kinematics of lower extremity and trunk positions, kinetics (including ground reaction forces, moments, power, and work). [ Time Frame: Post Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
persons who have sustained a stroke within greater than 6 months ago and less than 5 years.
Behavioral: locomotor training
Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age >= 18,
  2. stroke within past 6 months to 5 years,
  3. residual paresis in the lower extremity (Fugl-Meyer LE motor score < 34),
  4. ability to sit unsupported for 30 seconds,
  5. ability to walk at least 10 feet with maximum 1 person assist,
  6. self selected 10 meter gait speed less than 0.8 m/s,
  7. ability to follow a three step command,
  8. provision of informed consent, and
  9. successful completion of an exercise tolerance test

Exclusion Criteria:

  1. Lived in nursing home prior to stroke,
  2. Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters,
  3. Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded,
  4. History of serious chronic obstructive pulmonary disease or oxygen dependence,
  5. Severe weight bearing pain,
  6. Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, or previous stroke with residual neurological deficits,
  7. History of major head trauma,
  8. Lower extremity amputation,
  9. Non-healing ulcers on the lower extremity,
  10. Renal dialysis or end stage liver disease,
  11. Legal blindness or severe visual impairment,
  12. A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, schizophrenia or medication refractory depression,
  13. Life expectancy less than one year,
  14. Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10, knee flexion ROM < 90, hip flexion contracture > 25, and ankle plantar flexion contracture > 15,
  15. History of sustained alcoholism or drug abuse in the last six months,
  16. major post-stroke depression (PHQ-9 10),
  17. History of deep venous thrombosis or pulmonary embolism within 6 months,
  18. Uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions,
  19. Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest,
  20. Previous or current enrollment in a clinical trial to enhance stroke motor recovery,
  21. Lives more than 50 miles from the training sites,
  22. Unable to travel 3 times per week for outpatient training programs, and
  23. Intracranial hemorrhage related to aneurysmal rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded).

Inclusion and Exclusion criteria will be determined by a chart review, depression screen and subject interview by study physician or project coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review our inclusion and exclusion criteria and provide a letter supporting inclusion in the study. All subjects who meet selection criteria must successfully complete an exercise tolerance test.

  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: NCT00715299

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
Principal Investigator: Steve A. Kautz, PhD MS BS North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Kautz, Steve - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00715299     History of Changes
Other Study ID Numbers: B3983R
Study First Received: July 10, 2008
Last Updated: May 9, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 25, 2014