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

March 7, 2016 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Arm 1: High-Intensity Program
High-intensity treadmill-based exercise
Behavioral: High-intensity Treadmill Exercise
High-intensity treadmill walking program
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alyssa D Stookey, PhD MS, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • O7194-W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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