Locomotor Training (Walking Therapy) Post Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00715299
Recruitment Status : Completed
First Posted : July 15, 2008
Results First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Behavioral: locomotor training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms of Response to Locomotor Training After Stroke
Study Start Date : June 2005
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Locomotor Training Group
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.

Primary Outcome Measures :
  1. The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed. [ Time Frame: Pre and post Treatment ]
    Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00715299

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

Responsible Party: VA Office of Research and Development Identifier: NCT00715299     History of Changes
Other Study ID Numbers: B3983-R
First Posted: July 15, 2008    Key Record Dates
Results First Posted: March 5, 2015
Last Update Posted: March 5, 2015
Last Verified: February 2015

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