Comparison Between Custom and Non-custom Serious Games Poststroke

NCT ID: NCT06463730

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-19

Study Completion Date

2024-07-30

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self-paced first, non-custom first

Order of interventions: self-paced non-custom games, self-paced custom games, game-paced non-custom games, game-paced custom games

Group Type EXPERIMENTAL

Serious games

Intervention Type BEHAVIORAL

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

Self-paced first, custom first

Order of interventions: self-paced custom games, self-paced non-custom games, game-paced custom games, game-paced non-custom games

Group Type EXPERIMENTAL

Serious games

Intervention Type BEHAVIORAL

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

Game-paced first, non-custom first

Order of interventions: game-paced non-custom games, gam-paced custom games, self-paced non-custom games, self-paced custom games

Group Type EXPERIMENTAL

Serious games

Intervention Type BEHAVIORAL

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

Game-paced first, custom first

Order of interventions: game-paced custom games, game-paced non-custom games, self-paced custom games, self-paced non-custom games

Group Type EXPERIMENTAL

Serious games

Intervention Type BEHAVIORAL

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

Interventions

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Serious games

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urška Puh, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University Rehabilitation Institute, Republic of Slovenia

Locations

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University Rehabilitation Institute, Republic of Slovenia

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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URIS202402

Identifier Type: -

Identifier Source: org_study_id

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