Promoting Recovery Optimization With WALKing Exercise After Stroke (PROWALKS)

October 24, 2024 updated by: University of Delaware
Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.

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.

Detailed Description

As a group, stroke survivors are more physically inactive than even the most sedentary older adults. Lack of physical activity has serious consequences in persons with stroke, including an increased risk of recurrent stroke, developing other diseases and mortality. Current rehabilitation interventions do little to improve real-world walking activity after stroke, suggesting that simply improving walking capacity is not sufficient for improving daily physical activity after stroke. Rather, the investigator's hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone. Data from the investigator's lab provides support for this hypothesis; however, it suggests that the greater efficacy of combining the 2 interventions depends on a participant's initial walking activity. Thus, the investigator's do not expect that one intervention will be superior to the others for all participants, but rather that the combined intervention will be superior for those with low levels of baseline walking activity, speed and endurance. The specific objective of this study is to test whether and for whom combining fast walking training with a step activity monitoring program (FAST+SAM) is superior in improving real-world walking activity compared to fast walking training alone (FAST) or a step activity monitoring and feedback program alone (SAM) in those with chronic stroke. Using a randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors, will complete 12 weeks of fast walking training (FAST), a step activity monitoring program (SAM) or a fast walking training + step activity monitoring program (FAST+SAM). Moderation of specific intervention outcomes by baseline characteristics will be evaluated to determine for whom the interventions are effective.

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.
250

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
    • Delaware
      • Newark, Delaware, United States, 19712
        • University of Delaware

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

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 21-85
  2. Chronic stroke (>6 months post stroke)
  3. Able to walk at self-selected speed without assistance from another person (assistive devices are allowed)
  4. Self-selected walking speed >0.3 m/s and <1.0 m/s
  5. Average steps/day <8,000
  6. Resting heart rate between 40-100 beats per minute
  7. Resting blood pressure between 90/60 to 170/90.

Exclusion Criteria:

  1. Evidence of cerebellar stroke
  2. Other potentially disabling neurologic conditions in addition to stroke
  3. Lower limb Botulinum toxin injection <4 months earlier
  4. Current participation in physical therapy
  5. Inability to walk outside the home prior to the stroke
  6. Coronary artery bypass graft, stent placement or myocardial infarction within past 3 months
  7. Musculoskeletal pain that limits activity
  8. Inability to communicate with investigators
  9. score >1 on question 1b and >0 on question 1c on the NIH Stroke Scale.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

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.
Experimental: FAST+SAM
Subjects participate in fast walking training in combination with a step activity monitoring program
Behavioral: FAST+SAM
Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
Active Comparator: FAST alone
Subjects participate in fast walking training
Behavioral: FAST alone
Subjects participate in fast walking training 3x/week for 12 weeks.
Active Comparator: SAM alone
Subjects participate in a step activity monitoring program
Behavioral: SAM alone
Subjects participate in a step activity monitoring program 3x/week for 12 weeks

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
Steps Per Day
Time Frame: Change from Baseline to 3 months (Post)
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Change from Baseline to 3 months (Post)
Steps Per Day
Time Frame: Change from 3 months (Post) to 6 months
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Change from 3 months (Post) to 6 months
Steps Per Day
Time Frame: Change from 3 months (Post) to 12 months
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Change from 3 months (Post) to 12 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
Six-minute Walk Test Distance
Time Frame: Change from Baseline to 3 months (Post)
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Change from Baseline to 3 months (Post)
Six-minute Walk Test Distance
Time Frame: Change from 3 months (Post) to 6 months
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Change from 3 months (Post) to 6 months
Six-minute Walk Test Distance
Time Frame: Change from 3 months (Post) to 12 months
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Change from 3 months (Post) to 12 months
Self-selected Gait Speed
Time Frame: Change from Baseline to 3 months (Post)
change between two time points in average self-selected speed on the 10m walk test
Change from Baseline to 3 months (Post)
Self-selected Gait Speed
Time Frame: Change from 3 months (Post) to 6 months
change between two time points in average self-selected speed on the 10m walk test
Change from 3 months (Post) to 6 months
Self-selected Gait Speed
Time Frame: Change from 3 months (Post) to 12 months
change between two time points in average self-selected speed on the 10m walk test
Change from 3 months (Post) to 12 months
Oxygen Consumption
Time Frame: Change from Baseline to 3 months (Post)
change between two time points in average oxygen consumption at ventilatory threshold
Change from Baseline to 3 months (Post)
Oxygen Consumption
Time Frame: Change from 3 months (Post) to 6 months
change between two time points in average oxygen consumption at ventilatory threshold
Change from 3 months (Post) to 6 months
Oxygen Consumption
Time Frame: Change from 3 months (Post) to 12 months
change between two time points in average oxygen consumption at ventilatory threshold
Change from 3 months (Post) to 12 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.
University of Delaware

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
Christiana Care Health Services
Indiana University

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: Darcy Reisman, PT, PhD, University of Delaware

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 18, 2016

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, 2023

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.
December 1, 2023

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).
July 11, 2016

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.
July 15, 2016

First Posted (Estimated)

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.
July 18, 2016

Study Record Updates

Last Update Posted (Actual)

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.
October 28, 2024

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.
October 24, 2024

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, 2024

More Information

Terms related to this study

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.
  • NIH 1R01HD086362-01A1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be deposited in the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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