Exercise Intensity and Video Games: Persons Post-stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by

About this trial
This is an interventional other trial for Stroke focused on measuring active video games, virtual reality, exercise intensity, Parkinson Disease
Eligibility Criteria
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.
Sites / Locations
- School of Health Professions
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single
Arm Description
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.
Outcomes
Primary Outcome Measures
Neuromuscular intensity
movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout
Cardiovascular intensity (metabolic Units)
metabolic units measured continuously during each exercise bout
Cardiovascular intensity (Percent of maximum heart rate)
the percent of the maximum heart rate
Enjoyment
measured with the PACES questionnaire after each exercise bout
Borg Rate if Perceived Exertion Scale
Measures perception of effort on a scale of 6-20
Secondary Outcome Measures
Preference ranking
ranking exercise preference from highest (1) to lowest (4)
Fugl Meyer Motor Assessment Scale_ Lower Extremity Section
measure of lower extremity motor recovery
Full Information
NCT ID
NCT04538326
First Posted
April 7, 2020
Last Updated
August 28, 2020
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04538326
Brief Title
Exercise Intensity and Video Games: Persons Post-stroke
Official Title
Exercise Intensity During Interactive Video Games and Standard of Care of Individuals Post-Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
active video games, virtual reality, exercise intensity, Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measures, counter-balanced
Masking
None (Open Label)
Masking Description
Participants were told that the purpose of the study was to learn more about what type of exercise they liked. There was no indication that intensity was an outcome measure.
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Video Game Play, Standard of Care Stepping Activities
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuromuscular intensity
Description
movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout
Time Frame
collected continuously during each of the four conditions. Collected in a single 2 hour session
Title
Cardiovascular intensity (metabolic Units)
Description
metabolic units measured continuously during each exercise bout
Time Frame
collected continuously during each of the four conditions. Collected in a single 2 hour session
Title
Cardiovascular intensity (Percent of maximum heart rate)
Description
the percent of the maximum heart rate
Time Frame
collected continuously during each of the four conditions. Collected in a single 2 hour session
Title
Enjoyment
Description
measured with the PACES questionnaire after each exercise bout
Time Frame
four times collected in a single 2 hour session (once at the completion of each the four conditions).
Title
Borg Rate if Perceived Exertion Scale
Description
Measures perception of effort on a scale of 6-20
Time Frame
Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session
Secondary Outcome Measure Information:
Title
Preference ranking
Description
ranking exercise preference from highest (1) to lowest (4)
Time Frame
collected once at the end of the completed data collection of a 2 hour session
Title
Fugl Meyer Motor Assessment Scale_ Lower Extremity Section
Description
measure of lower extremity motor recovery
Time Frame
collected once during the single 2 hour data collection session
Other Pre-specified Outcome Measures:
Title
Open ended questions
Description
questions about preference and exertion and anything else the participants wants to share
Time Frame
collected once during a single 2 hour data collection session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Deutsch, PT, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Professions
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07011
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23897906
Citation
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.
Results Reference
result
PubMed Identifier
25198864
Citation
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.
Results Reference
result
PubMed Identifier
33853608
Citation
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.
Results Reference
derived
Learn more about this trial
Exercise Intensity and Video Games: Persons Post-stroke
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