StrokeSeriousGamesNCT06463730
Comparison Between Custom and Non-custom Serious Games Poststroke
A study testing Serious games in people with Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Serious games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSlovenia
- Study dates
- 19 Apr 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- additional neurological condition
- musculoskeletal impairments that would interfere with execution of the required tasks or completing the questionnaires
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Serious games
- Keywords
- Chronic stroke, Active video games, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious gamesBehavioural
Custom games played using the Equio system, non-custom Wii Fit games played using the Nintendo Wii Balance Board
| Study group | Role | What they receive |
|---|---|---|
| Self-paced first, non-custom first | Experimental | Order of interventions: self-paced non-custom games, self-paced custom games, game-paced non-custom games, game-paced custom games Receives: Behavioral: Serious games |
| Self-paced first, custom first | Experimental | Order of interventions: self-paced custom games, self-paced non-custom games, game-paced custom games, game-paced non-custom games Receives: Behavioral: Serious games |
| Game-paced first, non-custom first | Experimental | Order of interventions: game-paced non-custom games, gam-paced custom games, self-paced non-custom games, self-paced custom games Receives: Behavioral: Serious games |
| Game-paced first, custom first | Experimental | Order of interventions: game-paced custom games, game-paced non-custom games, self-paced custom games, self-paced non-custom games Receives: Behavioral: Serious games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of repetitions
Number of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software
Measured: On the day of the intervention during each game (anticipated duration: 5 minutes)
Amplitude
Amplitude of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software
Measured: On the day of the intervention during each game (anticipated duration: 5 minutes)
Secondary outcomes (4)
Users' enjoyment
Assessed using the Modified Physical Activity Enjoyment Scale (scale score expressed as percentage; higher scores mean a better outcome)
Measured: On the day of the intervention after each game (anticipated: every 5 minutes)
Flow state
Assessed using the Flow State Scale for Occupational Tasks (scale score range 14-98; higher scores mean a better outcome)
Measured: On the day of the intervention after each game (anticipated: every 5 minutes)
Likeability
Rated on a scale from 1 (least liked) to 6 (most liked)
Measured: On the day of the intervention after each game (anticipated: every 5 minutes)
Perception of exertion
Assessed using the Borg's Scale (scale score range 6-20; higher scores mean a worse outcome)
Measured: On the day of the intervention after each game (anticipated: every 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start19 Apr 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urška Puh, PT, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463730
- Sponsor's protocol ID
- URIS202402
- Acronym
- SeriousGames
- Status last verified
- Oct 2024
- First submitted
- 18 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06463730
- Acronym / sponsor ID
- SeriousGames / URIS202402
- Conditions
- Stroke
- Keywords
- Chronic stroke, Active video games, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self-paced first, non-custom first | Experimental | Behavioral: Serious gamesOrder of interventions: self-paced non-custom games, self-paced custom games, game-paced non-custom games, game-paced custom games |
| Self-paced first, custom first | Experimental | Behavioral: Serious gamesOrder of interventions: self-paced custom games, self-paced non-custom games, game-paced custom games, game-paced non-custom games |
| Game-paced first, non-custom first | Experimental | Behavioral: Serious gamesOrder of interventions: game-paced non-custom games, gam-paced custom games, self-paced non-custom games, self-paced custom games |
| Game-paced first, custom first | Experimental | Behavioral: Serious gamesOrder of interventions: game-paced custom games, game-paced non-custom games, self-paced custom games, self-paced non-custom games |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- additional neurological condition
- musculoskeletal impairments that would interfere with execution of the required tasks or completing the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serious gamesCustom games played using the Equio system, non-custom Wii Fit games played using the Nintendo Wii Balance Board | Behavioural | Game-paced first, custom first, Game-paced first, non-custom first, Self-paced first, custom first, Self-paced first, non-custom first |
Primary outcome
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
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
4 secondary outcomes
Users' enjoyment
Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)
Flow state
Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)
Likeability
Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)
Perception of exertion
Time frame: On the day of the intervention after each game (anticipated: every 5 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
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Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urška Puh, PT, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious games in people with Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of repetitions (time frame: On the day of the intervention during each game (anticipated duration: 5 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.