NCT06463730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 19, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

April 18, 2024

Last Update Submit

October 11, 2024

Conditions

Stroke

Keywords

Chronic strokeActive video gamesBalance

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (4)

  • Users' enjoyment

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

  • Flow state

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

  • Likeability

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

  • Perception of exertion

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

Study Arms (4)

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

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

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

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

Behavioral: Serious games

Interventions

Serious gamesBEHAVIORAL

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

Game-paced first, custom firstGame-paced first, non-custom firstSelf-paced first, custom firstSelf-paced first, non-custom first

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Urška Puh, PT, PhD

    University Rehabilitation Institute, Republic of Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

June 18, 2024

Study Start

April 19, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)