Ankle Robotics Training After Stroke

Completed

Phase N/A Results

Update History

20 Aug '14
A location was updated in Baltimore.
New
The overall status was removed for Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD.
10 Oct '13
The eligibility criteria were updated.
New
Inclusion Criteria: - Ischemic or hemorrhagic stroke >6 months prior in men or women aged between 18-80 years. - Clear indications of hemiparetic gait by clinical observation. - Completed all conventional physical therapy. - Ability to walk on a treadmill with handrail support. Exclusion Criteria: - Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction. - Major clinical depression: CESD score > 16 and judgment of clinical depression - Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer - History of non-stroke neuromuscular disorder restricting gait. - Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer. - Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments). - Self-report of pregnancy
Old
Inclusion Criteria: 1. Ischemic or hemorrhagic stroke >6 months prior in men or women aged between 18-80 years. 2. Clear indications of hemiparetic gait by clinical observation. 3. Completed all conventional physical therapy. 4. Ability to walk on a treadmill with handrail support. Exclusion Criteria: 1. Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction. 2. Major clinical depression: CESD score > 16 and judgment of clinical depression 3. Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer 4. History of non-stroke neuromuscular disorder restricting gait. 5. Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer. 6. Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments). 7. Self-report of pregnancy
28 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Ischemic or hemorrhagic stroke >6 months prior in men or women aged between 18-80 years. 2. Clear indications of hemiparetic gait by clinical observation. 3. Completed all conventional physical therapy. 4. Ability to walk on a treadmill with handrail support. Exclusion Criteria: 1. Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction. 2. Major clinical depression: CESD score > 16 and judgment of clinical depression 3. Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer 4. History of non-stroke neuromuscular disorder restricting gait. 5. Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer. 6. Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments). 7. Self-report of pregnancy
Old
Inclusion Criteria: 1. Ischemic or hemorraghic stroke >6 months prior in men or women aged between 18-80 years. 2. Clear indications of hemiparetic gait by clinical observation. 3. Completed all conventional physical therapy. 4. Ability to walk on a treadmill with handrail support. Exclusion Criteria: 1. Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction. 2. Major clinical depression: CESD score > 16 and judgment of clinical depression 3. Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer 4. History of non-stroke neuromuscular disorder restricting gait. 5. Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer. 6. Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments). 7. Self-report of pregnancy
25 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Ischemic or hemorraghic stroke >6 months prior in men or women aged between 18-80 years. 2. Clear indications of hemiparetic gait by clinical observation. 3. Completed all conventional physical therapy. 4. Ability to walk on a treadmill with handrail support. Exclusion Criteria: 1. Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction. 2. Major clinical depression: CESD score > 16 and judgment of clinical depression 3. Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer 4. History of non-stroke neuromuscular disorder restricting gait. 5. Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer. 6. Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments). 7. Self-report of pregnancy
Old
Inclusion Criteria: 1. Ischemic or hemorrhagic stroke >6 months prior in men or women aged between 18-80 years. 2. Clear indications of hemiparetic gait by clinical observation. 3. Completed all conventional physical therapy. 4. Ability to walk on a treadmill with handrail support. Exclusion Criteria: 1. Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction. 2. Major clinical depression: CESD score > 16 and judgment of clinical depression 3. Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer 4. History of non-stroke neuromuscular disorder restricting gait. 5. Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer. 6. Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments). 7. Self-report of pregnancy
A location was updated in Baltimore.
New
The overall status was updated to "Recruiting" at VA Maryland Health Care System, Baltimore.