Skeletal Muscle Properties and the Metabolic Cost of Walking Post-stroke

Completed

Phase 2 Results

Update History

31 Jul '15
Trial was updated to "Phase 2."
The eligibility criteria were updated.
New
Inclusion Criteria: - age 18-80; - stroke within past 6 months - 5 years; - residual paresis in the lower extremity (LE) (Fugl-Meyer motor score <34); - ability to sit unsupported for 30 sec; - ability to walk at least 10 ft with maximum 1 person assist; - self selected 10 meter gait speed < 0.8 m/s; and - provision of informed consent. Exclusion Criteria: - Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters; - history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living; - History of chronic obstructive pulmonary disease or oxygen dependence; - Preexisting neurological disorders, dementia or previous stroke; - History of major head trauma; - Legal blindness or severe visual impairment; - history of significant psychiatric illness; - Life expectancy <1 yr; - Severe arthritis or orthopedic problems that limit passive range of motion (ROM); - post-stroke depression (PHQ-9 10); - History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months; - Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions; - Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest; - Previous or current enrollment in a clinical trial to enhance motor recovery; - Presence of non-magnetic resonance (MR) compatible implants or devices, pregnancy or severe claustrophobia.
Old
Inclusion Criteria: - age 18-80; - stroke within past 6 months - 5 years; - residual paresis in the lower extremity (Fugl-Meyer LE motor score <34); - ability to sit unsupported for 30 sec; - ability to walk at least 10 ft with maximum 1 person assist; - self selected 10 meter gait speed < 0.8 m/s; and - provision of informed consent. Exclusion Criteria: - Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters; - history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living; - History of COPD or oxygen dependence; - Preexisting neurological disorders, dementia or previous stroke; - History of major head trauma; - Legal blindness or severe visual impairment; - history of significant psychiatric illness; - Life expectancy <1 yr; - Severe arthritis or orthopedic problems that limit passive ROM; - post-stroke depression (PHQ-9 10); - History of DVT or pulmonary embolism within 6 months; - Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions; - Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest; - Previous or current enrollment in a clinical trial to enhance motor recovery; - Presence of non-MR compatible implants or devices, pregnancy or severe claustrophobia.
5 Oct '13
The eligibility criteria were updated.
New
Inclusion Criteria: - age 18-80; - stroke within past 6 months - 5 years; - residual paresis in the lower extremity (Fugl-Meyer LE motor score <34); - ability to sit unsupported for 30 sec; - ability to walk at least 10 ft with maximum 1 person assist; - self selected 10 meter gait speed < 0.8 m/s; and - provision of informed consent. Exclusion Criteria: - Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters; - history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living; - History of COPD or oxygen dependence; - Preexisting neurological disorders, dementia or previous stroke; - History of major head trauma; - Legal blindness or severe visual impairment; - history of significant psychiatric illness; - Life expectancy <1 yr; - Severe arthritis or orthopedic problems that limit passive ROM; - post-stroke depression (PHQ-9 10); - History of DVT or pulmonary embolism within 6 months; - Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions; - Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest; - Previous or current enrollment in a clinical trial to enhance motor recovery; - Presence of non-MR compatible implants or devices, pregnancy or severe claustrophobia.
Old
Inclusion Criteria: 1. age 18-80; 2. stroke within past 6 months - 5 years; 3. residual paresis in the lower extremity (Fugl-Meyer LE motor score <34); 4. ability to sit unsupported for 30 sec; 5. ability to walk at least 10 ft with maximum 1 person assist; 6. self selected 10 meter gait speed < 0.8 m/s; and 7. provision of informed consent. Exclusion Criteria: 1. Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters; 2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living; 3. History of COPD or oxygen dependence; 4. Preexisting neurological disorders, dementia or previous stroke; 5. History of major head trauma; 6. Legal blindness or severe visual impairment; 7. history of significant psychiatric illness; 8. Life expectancy <1 yr; 9. Severe arthritis or orthopedic problems that limit passive ROM; 10. post-stroke depression (PHQ-9 10); 11. History of DVT or pulmonary embolism within 6 months; 12. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions; 13. Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest; 14. Previous or current enrollment in a clinical trial to enhance motor recovery; 15. Presence of non-MR compatible implants or devices, pregnancy or severe claustrophobia.
16 Dec '11
A location was updated in Charleston.
New
The overall status was removed for Ralph H. Johnson VA Medical Center, Charleston, SC.