Exercise Intensity and Video Games: Persons Post-stroke

August 28, 2020 updated by: Judith E Deutsch, PT, PhD, Rutgers, The State University of New Jersey

Exercise Intensity During Interactive Video Games and Standard of Care of Individuals Post-Stroke

Persons post stroke executed stepping activities under four conditions: standard of care, interacting with: an off-the-shelf Microsoft-Kinect game, with a self-paced repeated custom video game and a game-paced random custom video game. Exercise intensity (neuromuscular and cardiovascular), enjoyment and perceived effort were measured during and after each condition.

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

Persons post stroke were first familiarized with the four exercise conditions and then instrumented with a metabolic system and heart rate sensor. They played the games in two counter balanced blocks: repeated (standard of care and self-paced repeated custom) and random (Microsoft-Kinect game and game-paced random custom). Games were played for 8.5 minutes with ten minutes of rest in between so they could return to physiological baseline. During exercise they reported exertion and at the end of teach exercise trial they completed an enjoyment questionnaire. At the end of the first block, participants removed the metabolic system's mask and were assessed for motor recovery. Performances were video taped. At the end of data collection preferences for the activities were ranked and participants answered open ended questions. Data for neuromuscular and cardiovascular intensity, enjoyment and perceived effort were reduced and analyzed using a Repeated Measures Analysis of Variance (RMANOVA) with the appropriate post-hoc corrections. Where possible clinically meaningful changes were calculated.

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.
15

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
    • New Jersey
      • Newark, New Jersey, United States, 07011
        • School of Health Professions

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

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women post-stroke at least six months T
  • able to ambulate 100 feet without physical assistance but allowed to use assistive devices and orthotics,
  • able to stand for 3 minutes.
  • cleared for exercise with the PARQ.

Exclusion Criteria:

  1. history of severe heart disease, heart attack, valve replacement or coronary artery bypass surgery, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than stroke
  2. Are unable to follow directions.
  3. Do not have adequate vision and hearing ability (either aided or unaided with glasses, contacts or hearing aids
  4. Are unable to sign a consent form.
  5. Unstable medical condition or musculoskeletal disorder such as severe arthritis, knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to perform the required stepping for the games presented.
  6. Any other medical condition contraindications to exercise.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group 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: Single
Participants exercised in two counter balanced blocks: repeated (standard of care and self-paced repeated custom game) and random (Kinect game and game-paced random custom game). Exercise bouts were for 8.5 minutes with ten minutes of rest in between so they could return to physiological baseline. Data were collected in a single session lasting two hours.
Behavioral: Exercise
Participants performed stepping movements that were either cued by the investigator or interacted with a video game. There were three video game exercises that all involved stepping in either a repeated or a random pattern that was either self-paced or game paced.
Other Names:
  • Video Game Play
  • Standard of Care Stepping Activities

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
Neuromuscular intensity
Time Frame: collected continuously during each of the four conditions. Collected in a single 2 hour session
movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout
collected continuously during each of the four conditions. Collected in a single 2 hour session
Cardiovascular intensity (metabolic Units)
Time Frame: collected continuously during each of the four conditions. Collected in a single 2 hour session
metabolic units measured continuously during each exercise bout
collected continuously during each of the four conditions. Collected in a single 2 hour session
Cardiovascular intensity (Percent of maximum heart rate)
Time Frame: collected continuously during each of the four conditions. Collected in a single 2 hour session
the percent of the maximum heart rate
collected continuously during each of the four conditions. Collected in a single 2 hour session
Enjoyment
Time Frame: four times collected in a single 2 hour session (once at the completion of each the four conditions).
measured with the PACES questionnaire after each exercise bout
four times collected in a single 2 hour session (once at the completion of each the four conditions).
Borg Rate if Perceived Exertion Scale
Time Frame: Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session
Measures perception of effort on a scale of 6-20
Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session

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
Preference ranking
Time Frame: collected once at the end of the completed data collection of a 2 hour session
ranking exercise preference from highest (1) to lowest (4)
collected once at the end of the completed data collection of a 2 hour session
Fugl Meyer Motor Assessment Scale_ Lower Extremity Section
Time Frame: collected once during the single 2 hour data collection session
measure of lower extremity motor recovery
collected once during the single 2 hour data collection session

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Open ended questions
Time Frame: collected once during a single 2 hour data collection session
questions about preference and exertion and anything else the participants wants to share
collected once during a single 2 hour data collection session

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.
Rutgers, The State University of New Jersey

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: Judith Deutsch, PT, PhD, Rutgers University

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 (Actual)

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.
May 1, 2017

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.
August 30, 2018

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.
August 30, 2018

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).
April 7, 2020

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.
August 28, 2020

First Posted (Actual)

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.
September 4, 2020

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.
September 4, 2020

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.
August 28, 2020

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.
August 1, 2020

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.
  • Pro20160000916

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie the results of a publication will be available through the publishers repository. We

IPD Sharing Time Frame

Data will be made available through the appropriate journal data sharing plan.

IPD Sharing Access Criteria

For systematic reviews or other secondary analyses.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings