Task-oriented Training for Stroke: Impact on Function Mobility (TOTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01322607|
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident Stroke||Behavioral: High-intensity Treadmill Exercise Behavioral: Low-intensity Lifestyle Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Task-oriented Training for Stroke: Impact on Function Mobility|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2015|
Arm 1: High-Intensity Program
High-intensity treadmill-based exercise
Behavioral: High-intensity Treadmill Exercise
High-intensity treadmill walking program
Arm 2: Low-Intensity Program
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.
- Economy of Gait [ Time Frame: 3 months ]Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.
- Muscular Strength [ Time Frame: 3 months ]Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.
- Muscular Endurance [ Time Frame: 3 months ]Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.
- Balance [ Time Frame: 3 months ]Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322607
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Alyssa D Stookey, PhD MS||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|