Clinical trial NCT04538326: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: active video games
virtual reality
exercise intensity
Parkinson Disease
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures, counter-balanced
Primary purpose: OTHER

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.

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:

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.

Primary outcomes:
measure: Neuromuscular intensity
timeFrame: collected continuously during each of the four conditions. Collected in a single 2 hour session
measure: Cardiovascular intensity (metabolic Units)
timeFrame: collected continuously during each of the four conditions. Collected in a single 2 hour session
measure: Cardiovascular intensity (Percent of maximum heart rate)
timeFrame: collected continuously during each of the four conditions. Collected in a single 2 hour session
measure: Enjoyment
timeFrame: four times collected in a single 2 hour session (once at the completion of each the four conditions).
measure: Borg Rate if Perceived Exertion Scale
timeFrame: Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session
Secondary outcomes:
measure: Preference ranking
timeFrame: collected once at the end of the completed data collection of a 2 hour session
measure: Fugl Meyer Motor Assessment Scale_ Lower Extremity Section
timeFrame: collected once during the single 2 hour data collection session
Other outcomes:
measure: Open ended questions
timeFrame: collected once during a single 2 hour data collection session
Locations:
city: Newark
country: United States
facility: School of Health Professions
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Judith Deutsch, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.