Task-oriented Training for Stroke: Impact on Function Mobility "TOTS"

Completed

Phase N/A Results

Update History

7 Apr '16
The Summary of Purpose was updated.
New
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.
Old
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.
The eligibility criteria were updated.
New
Inclusion Criteria: - Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. - Completion of all regular post-stroke physical therapy - Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. - Able to rise from a chair unaided. - Able to walk 10 meters without human assistance. Exclusion Criteria: - Regular structured aerobic exercise (> 2x week). - Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. - Clinical history of - unstable angina, - recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), - hemodynamically significant valvular dysfunction, - Peripheral Arterial Obstructive Disease with claudication, - major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, - pulmonary or renal failure, - poorly controlled hypertension (>190/110), measured on at least two separate occasions - recent hospitalization for severe disease or surgery - severe or global receptive aphasia which confounds reliable testing and training. - Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of >16 and confirmed by clinical interview. - Pregnancy.
Old
Inclusion Criteria: - Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. - Completion of all regular post-stroke physical therapy - Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. - Able to rise from a chair unaided. - Able to walk 10 meters without human assistance. Exclusion Criteria: - Regular structured aerobic exercise (> 2x week). - Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. - Clinical history of - unstable angina, - recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), - hemodynamically significant valvular dysfunction, - PAOD with claudication, - major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, - pulmonary or renal failure, - poorly controlled hypertension (>190/110), measured on at least two separate occasions - recent hospitalization for severe disease or surgery - severe or global receptive aphasia which confounds reliable testing and training. - Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. - Pregnancy.
19 Sep '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.
22 Apr '14
The eligibility criteria were updated.
New
Inclusion Criteria: - Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. - Completion of all regular post-stroke physical therapy - Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. - Able to rise from a chair unaided. - Able to walk 10 meters without human assistance. Exclusion Criteria: - Regular structured aerobic exercise (> 2x week). - Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. - Clinical history of - unstable angina, - recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), - hemodynamically significant valvular dysfunction, - PAOD with claudication, - major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, - pulmonary or renal failure, - poorly controlled hypertension (>190/110), measured on at least two separate occasions - recent hospitalization for severe disease or surgery - severe or global receptive aphasia which confounds reliable testing and training. - Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. - Pregnancy.
Old
Inclusion Criteria: - Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. - Completion of all regular post-stroke physical therapy - Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. - Able to rise from a chair unaided. - Able to walk 10 meters without human assistance. Exclusion Criteria: - Regular structured aerobic exercise (> 2x week). - Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. - Clinical history of (a) unstable angina, (b) recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), (c) hemodynamically significant valvular dysfunction, (d) PAOD with claudication, (e) major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, (f) pulmonary or renal failure, (g) poorly controlled hypertension (>190/110), measured on at least two separate occasions (h) recent hospitalization for severe disease or surgery (i) severe or global receptive aphasia which confounds reliable testing and training. - Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. - Pregnancy.
20 Nov '13
A location was updated in Baltimore.
New
The overall status was removed for VA Maryland Health Care System, Baltimore.
14 Jun '13
The eligibility criteria were updated.
New
Inclusion Criteria: - Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. - Completion of all regular post-stroke physical therapy - Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. - Able to rise from a chair unaided. - Able to walk 10 meters without human assistance. Exclusion Criteria: - Regular structured aerobic exercise (> 2x week). - Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. - Clinical history of (a) unstable angina, (b) recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), (c) hemodynamically significant valvular dysfunction, (d) PAOD with claudication, (e) major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, (f) pulmonary or renal failure, (g) poorly controlled hypertension (>190/110), measured on at least two separate occasions (h) recent hospitalization for severe disease or surgery (i) severe or global receptive aphasia which confounds reliable testing and training. - Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. - Pregnancy.
Old
Inclusion Criteria: 1. Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. 2. Completion of all regular post-stroke physical therapy 3. Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. 4. Able to rise from a chair unaided. 5. Able to walk 10 meters without human assistance. Exclusion Criteria: 1. Regular structured aerobic exercise (> 2x week). 2. Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. 3. Clinical history of (a) unstable angina, (b) recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), (c) hemodynamically significant valvular dysfunction, (d) PAOD with claudication, (e) major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, (f) pulmonary or renal failure, (g) poorly controlled hypertension (>190/110), measured on at least two separate occasions (h) recent hospitalization for severe disease or surgery (i) severe or global receptive aphasia which confounds reliable testing and training. 4. Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. 5. Pregnancy.
12 Jan '13
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. 2. Completion of all regular post-stroke physical therapy 3. Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. 4. Able to rise from a chair unaided. 5. Able to walk 10 meters without human assistance. Exclusion Criteria: 1. Regular structured aerobic exercise (> 2x week). 2. Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. 3. Clinical history of (a) unstable angina, (b) recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), (c) hemodynamically significant valvular dysfunction, (d) PAOD with claudication, (e) major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, (f) pulmonary or renal failure, (g) poorly controlled hypertension (>190/110), measured on at least two separate occasions (h) recent hospitalization for severe disease or surgery (i) severe or global receptive aphasia which confounds reliable testing and training. 4. Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. 5. Pregnancy.
Old
Inclusion Criteria: 1. Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. 2. Completion of all regular post-stroke physical therapy 3. Adequaate language and neurocognitive function to participate in testing and training and to give adequate informed consent. 4. Able to rise from a chair unaided. 5. Able to walk 10 meters without human assistance. Exclusion Criteria: 1. Regular structured aerobic exercise (> 2x week). 2. Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. 3. Clinical history of (a) unstable angina, (b) recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), (c) hemodynamically significant valvular dysfunction, (d) PAOD with claudication, (e) major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, (f) pulmonary or renal failure, (g) poorly controlled hypertension (>190/110), measured on at least two separate occasions (h) recent hospitalization for severe disease or surgery (i) severe or global receptive aphasia which confounds reliable testing and training. 4. Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview. 5. Pregnancy.