Towards a novel approach for physical therapy: integrating Mixed Reality into practice.

Towards a novel approach for physical therapy: integrating Mixed Reality into practice. - Play it, Move it, Improve it.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57652

Enrollment

Registered

2025-06-16

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverse aandoeningen waarvoor kinderen zijn opgenomen op de PICU of PCC Various conditions for which children are admitted to the PICU or PCC

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the three different populations are: 1) Feasibility in children and their parents (population 1) In order to be eligible to participate, a child must meet all of the following criteria: - Aged 5 to 18 years - Admitted to the Pediatric Intensive Care Unit (PICU) or the Pediatric Chest Center (PCC) - Children in the PICU are comfortable and awake, COMFORT score between 11-22 - An indication for physical therapy - An expected hospital stay of 3 days or longer - Ability to follow instructions for physical therapy - Communicable and able to assess the questionnaires - Written informed consent must be obtained from child (>=12 years) and/or legal representative 2) Health care professionals (population 2) In order to be eligible to participate, a subject must meet all of the following criteria: - Working at the PICU or PCC as health care professional - Involved in the care of a child receiving physical therapy with MR - Communicable and able to assess the questionnaires - Written informed consent (signed and dated) must be obtained 3) Co-creation session (population 3) In order to be eligible to participate, a child must meet all of the following criteria: - Aged 8 to 18 years - Recovered children, discharged from the hospital and back at home - Admitted to the PICU or PCC between January 1st 2022 and June 1st 2024 - Communicable and able to read and write Dutch - Written informed consent must be obtained from child (>=12 years) and/or legal representative

Exclusion criteria

Exclusion criteria: Exclusion criteria for the three different populations are: 1) Feasibility in children and their parents (population 1) A potential subject who meets any of the following criteria will be excluded to participate: - Inability to provide informed consent for both the child and/or parents - Lack of proficiency in the Dutch language for both the child and/or parents - Severe intellectual development disorder - Acute spinal cord or brain injuries - Patients with respiratory or hemodynamic instability - Patients with mobilization safety criteria 1 or 2 according clinical protocol (KMS protocol Early Mobilization): a) invasive respiratory support with FiO2>60% and PEEP>6; b) hemodynamic instability receiving 1 or more vasoactive drugs by infusion - Patients with a delirium score of 4 or higher - Physical impairment or medical treatment that preclude MR intervention as assessed by the health care professional (e.g. facial burns or wounds, contagious infectious disease) 2) Health care professional (population 2) A potential subject who meets any of the following criteria will be excluded to participate: - Not involved in the care of a child receiving MR and physical therapy - Not willing to participate 3) Co-creation session (population 3) A potential subject who meets any of the following criteria will be excluded to participate: - Lack of proficiency in the Dutch language for both the child and/or parents

Design outcomes

Primary

Measure	Time frame
Main study endpoints (feasibility, acceptability, tolerability and initial clinical efficacy) will be gathered in two study populations: 1 critically ill children and their parents and 2 involved health care professionals.	—

Secondary

Measure	Time frame
Next to data collection at the hospital, we will work on optimization of the MR games and will further tailor and build upon the existing products according to the needs and wishes of children that were admitted to the hospital. We will build upon the input from the interviews with children and parents, and the focus group with professionals in the co-creation sessions. To better understand the needs and wishes of children while playing the MR games, the following topics will be explored during the co-creation sessions: the type of guidance during the games (e.g. text, voice-over, avatar), the role of other people during play (e.g. working together, competition, leaderboards), the type of interactions during the games (e.g. playful, realistic), the level of immersion (e.g. virtual realities, mixed realities, augmented realities). We will organize two co-creation sessions (±100 minutes each) with 4 children per session (total of 8 children) who were previously admitted to PICU/PCC at Erasmus MC. The session will be hosted at Erasmus MC and facilitated by two experts on design and co-creation from TU Delft. During the co-creation sessions, people from HoloMoves will demonstrate the MR games to the children, and an independent researcher from our team will participate and collect the data. In the co-creation workshop activities, we will explore the preferences of the children on the topics mentioned above. After consent of all participants, we will video record the sessions and make photographs of the output (e.g. post-its, written insights, feedback and comments). Afterwards, the recording will be transcribed and anonymized, and Personal Identifiable Information will be removed from the photographs. The original photographs and recording will be removed afterwards.	—

Measure

Time frame

Next to data collection at the hospital, we will work on optimization of the MR games and will further tailor and build upon the existing products according to the needs and wishes of children that were admitted to the hospital. We will build upon the input from the interviews with children and parents, and the focus group with professionals in the co-creation sessions. To better understand the needs and wishes of children while playing the MR games, the following topics will be explored during the co-creation sessions: the type of guidance during the games (e.g. text, voice-over, avatar), the role of other people during play (e.g. working together, competition, leaderboards), the type of interactions during the games (e.g. playful, realistic), the level of immersion (e.g. virtual realities, mixed realities, augmented realities). We will organize two co-creation sessions (±100 minutes each) with 4 children per session (total of 8 children) who were previously admitted to PICU/PCC at Erasmus MC. The session will be hosted at Erasmus MC and facilitated by two experts on design and co-creation from TU Delft. During the co-creation sessions, people from HoloMoves will demonstrate the MR games to the children, and an independent researcher from our team will participate and collect the data. In the co-creation workshop activities, we will explore the preferences of the children on the topics mentioned above. After consent of all participants, we will video record the sessions and make photographs of the output (e.g. post-its, written insights, feedback and comments). Afterwards, the recording will be transcribed and anonymized, and Personal Identifiable Information will be removed from the photographs. The original photographs and recording will be removed afterwards.

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Countries

Netherlands

Outcome results