NCT07460778

Brief Summary

This clinical study has been organised to identify the needs and recommendations of experts in the field of rehabilitation technology and gamification on the development of serious games for rehabilitation. Based on the information gathered we aim to construct a blueprint for the development of serious games for rehabilitation that maximizes clinical outcomes and the effective implementation in rehabilitation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

February 25, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

Delphi studySerious games for rehabilitationRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Information on the development process of serious games for rehabilitation

    Throughout the Delphi study, qualitative data will be collected (online surveys, focus group discussions, etc.) from experts in the field of serious games for rehabilitation on what methods and/or tools shoudl be used in the development process of serious games for rehabilitation. This data will be collected for all different stages of the development process. Furthermore, overarching key principles that span across all stages of development will also be identified based on expert opinion.

    Through study completion, on average 1 year

Study Arms (3)

Phase 1

OTHER

The first phase consists of an online survey aimed at identifying important tools and methodologies for each stage of development, as well as across all stages of development. To structure this survey the TRL model will be used as a conceptual framework (appendix 1). The different levels of the model will be used as stages of development to base the questions on. However, the aim is not to strictly adhere to this model, but to gather input on what methods should be used and what can be adjusted from existing models such as the TRL model to maximize adoption of serious games into care. Furthermore, the survey will try to identify key principles that should be taken into account across the entire developmental process of serious games for rehabilitation. These key principles, such as a user-centered approach, working evidence-based, maximizing engagement of end-users, etc., are the foundation for the developmental process and should be adhered to throughout the entire process.

Other: Online survey

Phase 2

OTHER

The second phase consists of focus groups that will be organized to discuss the results of the online survey and add missing data if needed. The focus group discussions will also be structured based on the TRL model used during the survey and will expand on the results mentioned by the experts (appendix 2 and 3). After all focus group discussion are completed the results will be anonymized, aggregated and reported to the experts. This will provide them with the opportunity to further revise their answers based on all the results.

Other: Focus group discussions

Phase 3

OTHER

The third and final phase consists of consecutive online surveys in which the experts are asked to rank the different items that were mentioned in the previous phase on a five-point Likert scale (Appendix 4). Similar to the focus group discussions, the answers from these phases will be anonymized, aggregated and reported to the experts after each ranking phase. Experts will have the opportunity to revise their answers across multiple phases. This ranking process is repeated until consensus is reached for all stages. Consensus will be defined as percentage of agreement and the cut-off will be 75%, as a percentage between 70% and 80% is recommended in Delphi studies.

Other: Ranking results

Interventions

The first phase will consist of an online survey questionnaire aimed at identifying key development methods and tools for each stage of development. The survey will be structured using the Technology Readiness Level model and, by using open questions, experts will be asked to give their input on this model and the important items for each stage of development. Furthermore, the experts will be asked to identify the key principles that they find detrimental to the development of serious games for rehabilitation across all stages of development. Building on the results of this survey, focus group discussions will be organized.

Phase 1

The second phase of the modified Delphi study will consist of online focus group discussions (using Microsoft Teams) with 6 to 12 experts per session. First, a summary will be given of the results from the survey phase. Following this, the experts will be asked to revise and add onto these results for each stage of development. Additionally the experts will be asked to revise the key principles that span across all stages of development and add missing key principles. Lastly they will be asked to identify already existing methodologies or frameworks that incorporate some (or all) of the mentioned tools or methods.

Phase 2

In the next phase, experts will be asked to rank the different items mentioned during the focus group discussions on a five-point Likert scale through an online survey using Microsoft Forms. For each stage of development, the relevant items will be presented, and the experts will have to rank these items based on their importance (very important to not important at all) for the development of serious games for rehabilitation. The results from this phase will be anonymized and sent to the experts as feedback. Afterwards the experts will have the chance to revise their answers based on this feedback.

Phase 3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Experience with (the development of) serious games for rehabilitation

You may not qualify if:

  • No experience with (the development of) serious games for rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1090, Belgium

RECRUITING

Study Officials

  • Eva Swinnen

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Swinnen

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This study follows a modified Delphi methodology. Consecutive rounds will be organised, consisting of online surveys and focus group discussions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 10, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations