StrokeNCT04538326
Exercise Intensity and Video Games: Persons Post-stroke
A study testing Exercise in people with Stroke, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Health Professions
Newark, New Jersey, 07011
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Exercise
- Keywords
- active video games, virtual reality, exercise intensity, Parkinson Disease
- Medical subject headings
- Stroke, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Video Game Play, Standard of Care Stepping Activities
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.
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular intensity
movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout
Measured: collected continuously during each of the four conditions. Collected in a single 2 hour session
Cardiovascular intensity (metabolic Units)
metabolic units measured continuously during each exercise bout
Measured: collected continuously during each of the four conditions. Collected in a single 2 hour session
Cardiovascular intensity (Percent of maximum heart rate)
the percent of the maximum heart rate
Measured: collected continuously during each of the four conditions. Collected in a single 2 hour session
Enjoyment
measured with the PACES questionnaire after each exercise bout
Measured: four times collected in a single 2 hour session (once at the completion of each the four conditions).
Borg Rate if Perceived Exertion Scale
Measures perception of effort on a scale of 6-20
Measured: Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session
Secondary outcomes (2)
Preference ranking
ranking exercise preference from highest (1) to lowest (4)
Measured: collected once at the end of the completed data collection of a 2 hour session
Fugl Meyer Motor Assessment Scale_ Lower Extremity Section
measure of lower extremity motor recovery
Measured: collected once during the single 2 hour data collection session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 May 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures, counter-balanced
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith E Deutsch, PT, PhD, Rutgers, The State University of New Jersey
- Investigators
- Judith Deutsch, PT, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538326
- Sponsor's protocol ID
- Pro20160000916
- Status last verified
- Aug 2020
- First submitted
- 7 Apr 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie the results of a publication will be available through the publishers repository. We
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.
PubMed 23897906Kafri 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.
PubMed 25198864Deutsch 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.
PubMed 33853608
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intensity During Interactive Video Games and Standard of Care of Individuals Post-Stroke
- ClinicalTrials.gov ID
- NCT04538326
- Acronym / sponsor ID
- Pro20160000916
- Conditions
- Stroke
- Keywords
- active video games, virtual reality, exercise intensity, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures, counter-balanced
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Behavioral: ExerciseParticipants 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Video Game Play, Standard of Care Stepping ActivitiesParticipants 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. | Behavioural | Single |
Primary outcome
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
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
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
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
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
2 secondary outcomes
Preference ranking
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Results publication: PubMed 23897906Kafri 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 publication: PubMed 25198864Kafri 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.
- Derived from this study: PubMed 33853608Deutsch 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie the results of a publication will be available through the publishers repository. We
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Deutsch, PT, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Stroke, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular intensity (time frame: collected continuously during each of the four conditions. Collected in a single 2 hour session). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538326, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.