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Completed

NCT Number: NCT04538326

Exercise Intensity and Video Games: Persons 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.

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Key information

Conditions

Stroke Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health Professions

Newark, New Jersey, 07011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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)

  2. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 4, 2020
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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