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Completed

NCT Number: NCT06463730

Comparison Between Custom and Non-custom Serious Games Poststroke

Serious games for rehabilitation are delivered through systems that are either customised or non-customised. Custom serious games allow for control of feedback, setting of game speed and difficulty, while non-custom games are less adaptable but provide attractive graphics and sounds. The study compared the activity intensity and user experience of persons after stroke while playing custom and non-custom virtual reality balance games that were both game- and self-paced.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

About this study

Persons in chronic phase poststroke will play 12 games (6 self- and 6 game-paced games) over two sessions (in randomised order). Within each game-type, custom and non-custom games will be played in random order. All games will be played on a balance board, whereby each pair of a custom and non-custom game will require comparable movement directions of the center of pressure. The custom system will be compared to the non-custom system in terms of number of repetitions, movement amplitude, users' enjoyment, flow state, likeability and perception of exertion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic phase (>6 months) after stroke
  • ability to walk with supervision or independently with or without walking aid on flat ground or all surfaces
  • stable health condition
  • ability to follow simple instructions

Exclusion criteria

  • additional neurological condition
  • musculoskeletal impairments that would interfere with execution of the required tasks or completing the questionnaires

Treatment and study plan

Serious games

Behavioral

Custom games played using the Equio system, non-custom Wii Fit games played using the Nintendo Wii Balance Board

Primary outcomes

  1. Number of repetitions

    Time frame: On the day of the intervention during each game (anticipated duration: 5 minutes)

    Number of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software

  2. Amplitude

    Time frame: On the day of the intervention during each game (anticipated duration: 5 minutes)

    Amplitude of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software

Secondary outcomes

  1. Users' enjoyment

    Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)

    Assessed using the Modified Physical Activity Enjoyment Scale (scale score expressed as percentage; higher scores mean a better outcome)

  2. Flow state

    Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)

    Assessed using the Flow State Scale for Occupational Tasks (scale score range 14-98; higher scores mean a better outcome)

  3. Likeability

    Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)

    Rated on a scale from 1 (least liked) to 6 (most liked)

  4. Perception of exertion

    Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)

    Assessed using the Borg's Scale (scale score range 6-20; higher scores mean a worse outcome)

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Official study title

Comparison of Activity Intensity, Performance, and User's Experience Between Custom and Non-custom Serious Games Combined With Balance Boards for Persons After Stroke

Acronym: SeriousGames

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2024
Registry last updated
Oct 15, 2024

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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