- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538326
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
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
Interventional
Enrollment (Actual)
15
Phase
- 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
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New Jersey
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Newark, New Jersey, United States, 07011
- School of Health Professions
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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
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:
- 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
- Are unable to follow directions.
- Do not have adequate vision and hearing ability (either aided or unaided with glasses, contacts or hearing aids
- Are unable to sign a consent form.
- 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.
- 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 |
Intervention / Treatment |
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
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
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movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout
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collected continuously during each of the four conditions. Collected in a single 2 hour session
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Cardiovascular intensity (metabolic Units)
Time Frame: collected continuously during each of the four conditions. Collected in a single 2 hour session
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metabolic units measured continuously during each exercise bout
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collected continuously during each of the four conditions. Collected in a single 2 hour session
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Cardiovascular intensity (Percent of maximum heart rate)
Time Frame: collected continuously during each of the four conditions. Collected in a single 2 hour session
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the percent of the maximum heart rate
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collected continuously during each of the four conditions. Collected in a single 2 hour session
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Enjoyment
Time Frame: four times collected in a single 2 hour session (once at the completion of each the four conditions).
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measured with the PACES questionnaire after each exercise bout
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four times collected in a single 2 hour session (once at the completion of each the four conditions).
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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
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Measures perception of effort on a scale of 6-20
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Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session
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Secondary Outcome Measures
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
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ranking exercise preference from highest (1) to lowest (4)
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collected once at the end of the completed data collection of a 2 hour session
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Fugl Meyer Motor Assessment Scale_ Lower Extremity Section
Time Frame: collected once during the single 2 hour data collection session
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measure of lower extremity motor recovery
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collected once during the single 2 hour data collection session
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Open ended questions
Time Frame: collected once during a single 2 hour data collection session
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questions about preference and exertion and anything else the participants wants to share
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collected once during a single 2 hour data collection session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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
- Kafri M, Myslinski MJ, Gade VK, Deutsch JE. Energy expenditure and exercise intensity of interactive video gaming in individuals poststroke. Neurorehabil Neural Repair. 2014 Jan;28(1):56-65. doi: 10.1177/1545968313497100. Epub 2013 Jul 29.
- Kafri M, Myslinski MJ, Gade VK, Deutsch JE. High metabolic cost and low energy expenditure for typical motor activities among individuals in the chronic phase after stroke. J Neurol Phys Ther. 2014 Oct;38(4):226-32. doi: 10.1097/NPT.0000000000000053.
- Deutsch JE, James-Palmer A, Damodaran H, Puh U. Comparison of neuromuscular and cardiovascular exercise intensity and enjoyment between standard of care, off-the-shelf and custom active video games for promotion of physical activity of persons post-stroke. J Neuroeng Rehabil. 2021 Apr 14;18(1):63. doi: 10.1186/s12984-021-00850-2.
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)
May 1, 2017
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
August 30, 2018
Study Registration Dates
First Submitted
April 7, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
September 4, 2020
Study Record Updates
Last Update Posted (Actual)
September 4, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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