Locomotor Training (Walking Therapy) Post Stroke
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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 |
- 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 |
Inclusion Criteria:
- age >= 18,
- stroke within past 6 months to 5 years,
- residual paresis in the lower extremity (Fugl-Meyer LE motor score < 34),
- ability to sit unsupported for 30 seconds,
- ability to walk at least 10 feet with maximum 1 person assist,
- self selected 10 meter gait speed less than 0.8 m/s,
- ability to follow a three step command,
- provision of informed consent, and
- successful completion of an exercise tolerance test
Exclusion Criteria:
- Lived in nursing home prior to stroke,
- Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters,
- 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,
- History of serious chronic obstructive pulmonary disease or oxygen dependence,
- Severe weight bearing pain,
- Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, or previous stroke with residual neurological deficits,
- History of major head trauma,
- Lower extremity amputation,
- Non-healing ulcers on the lower extremity,
- Renal dialysis or end stage liver disease,
- Legal blindness or severe visual impairment,
- A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, schizophrenia or medication refractory depression,
- Life expectancy less than one year,
- 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,
- History of sustained alcoholism or drug abuse in the last six months,
- major post-stroke depression (PHQ-9 10),
- History of deep venous thrombosis or pulmonary embolism within 6 months,
- Uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions,
- Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest,
- Previous or current enrollment in a clinical trial to enhance stroke motor recovery,
- Lives more than 50 miles from the training sites,
- Unable to travel 3 times per week for outpatient training programs, and
- 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| United States, Florida | |
| North Florida/South Georgia Veterans Health System | |
| Gainesville, Florida, United States, 32608 | |
| 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 May 19, 2013