Task-oriented Training for Stroke: Impact on Function Mobility

Stroke Clinical Trial

— TOTS  

Official title:

Task-oriented Training for Stroke: Impact on Function Mobility

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01322607
• Other study ID #: O7194-W
• Status: Active, not recruiting
• Phase: N/A
• First received: March 22, 2011
• Last updated: September 17, 2014
• Start date: July 2011
• Est. completion date: January 2015

Study information

• Verified date: September 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• High-intensity Treadmill Exercise
High-intensity treadmill walking program
• Low-intensity Lifestyle Intervention
A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Economy of Gait		3 months	No
Secondary	Muscular strength		3 months	No
Secondary	Muscular endurance		3 months	No
Secondary	Balance		3 months	No