Clinical trial NCT06463730: Comparison Between Custom and Non-custom Serious Games Poststroke
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Chronic stroke
Active video games
Balance
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of repetitions
timeFrame: On the day of the intervention during each game (anticipated duration: 5 minutes)
measure: Amplitude
timeFrame: On the day of the intervention during each game (anticipated duration: 5 minutes)
Secondary outcomes:
measure: Users' enjoyment
timeFrame: On the day of the intervention after each game (anticipated: every 5 minutes)
measure: Flow state
timeFrame: On the day of the intervention after each game (anticipated: every 5 minutes)
measure: Likeability
timeFrame: On the day of the intervention after each game (anticipated: every 5 minutes)
measure: Perception of exertion
timeFrame: On the day of the intervention after each game (anticipated: every 5 minutes)
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Urška Puh, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: