Trial record 17 of 747 for:
Open Studies | "Stroke"
Task-oriented Training for Stroke: Impact on Function Mobility (TOTS)
This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01322607
First received: March 22, 2011
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebrovascular Accident Stroke |
Behavioral: High-intensity Treadmill Exercise Behavioral: Low-intensity Lifestyle Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Task-oriented Training for Stroke: Impact on Function Mobility |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Economy of Gait [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Muscular strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Muscular endurance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1
High-intensity treadmill-based exercise
|
Behavioral: High-intensity Treadmill Exercise
High-intensity treadmill walking program
|
|
Arm 2
Low-intensity lifestyle intervention (group exercise)
|
Behavioral: Low-intensity Lifestyle Intervention
A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322607
Contacts
| Contact: Alyssa D Stookey, PhD MS | (410) 605-7000 ext 5431 | alyssa.stookey@va.gov |
Locations
| United States, Maryland | |
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Alyssa D Stookey, PhD MS 410-605-7000 ext 5431 alyssa.stookey@va.gov | |
| Contact: Richard Macko (410) 605-7000 ext 5413 rmacko@grecc.umary.edu | |
| Principal Investigator: Alyssa D Stookey, PhD MS | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Alyssa D Stookey, PhD MS | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01322607 History of Changes |
| Other Study ID Numbers: | O7194-W |
| Study First Received: | March 22, 2011 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Exercise Rehabilitation Stroke |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013