Comparison Between Custom and Non-custom Serious Games Poststroke

Stroke Clinical Trial

— SeriousGames  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463730
• Other study ID #: URIS202402
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: Metka Moharic, MD, PhD
• Phone: +386 1 4758441
• Email: metka.moharic[@]ir-rs.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of repetitions	Number of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software	On the day of the intervention during each game (anticipated duration: 5 minutes)
Primary	Amplitude	Amplitude of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software	On the day of the intervention during each game (anticipated duration: 5 minutes)
Secondary	Users' enjoyment	Assessed using the Modified Physical Activity Enjoyment Scale (scale score expressed as percentage; higher scores mean a better outcome)	On the day of the intervention after each game (anticipated: every 5 minutes)
Secondary	Flow state	Assessed using the Flow State Scale for Occupational Tasks (scale score range 14-98; higher scores mean a better outcome)	On the day of the intervention after each game (anticipated: every 5 minutes)
Secondary	Likeability	Rated on a scale from 1 (least liked) to 6 (most liked)	On the day of the intervention after each game (anticipated: every 5 minutes)
Secondary	Perception of exertion	Assessed using the Borg's Scale (scale score range 6-20; higher scores mean a worse outcome)	On the day of the intervention after each game (anticipated: every 5 minutes)