Using Immersive Virtual Reality for Children's Lower Limb Rehabilitation
Condition: Virtual Reality; Physical Rehabilitation; Lower Limb Injury; Paediatric
MeSH terms: Leg Injuries
Study type: Interventional

Summary: 
      Patients who have undergone lower limb or knee surgery are often required to participate in
      rehabilitative exercises to regain or maximise movement and function in the affected leg.
      Physiotherapy interventions for rehabilitation can be painful, uncomfortable, and tedious,
      reducing compliance and limiting the movement and function achieved by the patient.

      Clinical studies have reported improvements in pain, compliance and outcomes by incorporating
      Virtual Reality (VR) into care. Evidence suggests that more Immersive VR (IVR) is effective
      in rehabilitation, while being cost-effective, with few adverse side-effects. Previous
      research by this team with adult burn patients and paediatric upper limb rehabilitation
      patients indicate that IVR could help reduce pain, increase compliance and improve care
      experiences and outcomes.

      The objective of the study is to investigate the feasibility and perceived impact of the
      Immersive Virtual Reality (IVR) intervention as a tool in physiotherapy rehabilitation for
      children (aged 11-16) after lower limb or knee surgery.
    

Detailed description: 
      The study will take the form of feasibility and proof of concept trial using IVR as a
      physiotherapy rehabilitation tool following lower limb or knee surgery for children (aged 11
      - 16). It will examine the feasibility, acceptability, usability, and efficacy of the IVR
      system from the perspectives of the children, parents and staff. The mixed-method approach
      (collecting quantitative and qualitative data):

      Assess changes in anxiety, pain and movement during daily physiotherapy rehabilitation
      sessions after surgery and before discharge from hospital, based on:

        -  Child's anxiety ratings before physiotherapy

        -  Child's pain ratings after physiotherapy

        -  Practitioner's ratings of movement during physiotherapy Assess child, parent / carer and
           staff perceptions of and satisfaction with IVR as a tool to enhance the experience and
           outcomes of physiotherapy.

      Assess the perceptions of therapeutic and clinical staff on the viability of the IVR as a
      tool for assisting in rehabilitation physiotherapy in the hospital setting.

      Procedure Before consent is taken, child participants will be offered a 5 minute exposure to
      the HMD IVR equipment and another similar game, to familiarise themselves with the equipment,
      check there are no problems, and avoid unnecessary distractions and confusion during the IVR
      scenario itself. Patients will then use the IVR during each physiotherapy session after
      surgery until their discharge from hospital, which is expected to comprise one 10 minute
      session per day for 3-5 days. During each session, child participants will rate their
      anxiety, perceived pain and feedback any feelings about the experience. Physiotherapists will
      record the range of movement and strength using standardised measures to check for
      improvements.

      Qualitative feedback will be gathered through interviews with children, their parents, and
      practitioners, focusing on experiences, satisfaction, effectiveness, acceptability, and
      practicality of the IVR intervention. Further feedback on IVR usability will be obtained from
      practitioners.

      Data Analyses Descriptive statistics for anxiety, pain and movement collected before, during
      and after physiotherapy sessions will be calculated. Repeated measures analyses will be
      conducted to assess changes over time in each outcome.

      Interpretive analyses will be conducted to establish whether demographic differences
      influence dependent variables.

      Findings for anxiety, pain and movement under IVR and for SUS (usability scale) ratings will
      also be compared with pre-existing norm-related evidence and other relevant published
      clinical outcomes from physiotherapy studies. However, in this small sample, statistical
      analyses will be treated tentatively. Future larger scale work will strengthen any tentative
      findings made from this small-scale feasibility study.

      Qualitative data from all interviews will be collated and analysed for themes which address
      the aims of the study using established thematic analysis processes. This will involve a
      process of careful reading, coding and comparison in order to identify important patterns in
      the data, focused on answering the aims of the study. Themes will be generated based upon the
      analysis process, which will be discussed and refined within the research team. Data will be
      stored, organised and analysed in NVivo.
    

Intervention name(s): Immersive Virtual Reality Lower Limb and Knee Rehabilitation
Intervention type(s): Device
Intervention description(s): Patients wore a VR headset while undergoing their rehabilitation session
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The study will take the form of feasibility and proof of concept trial using IVR as a physiotherapy rehabilitation tool following lower limb or knee surgery for children (aged 11 - 16). It will examine the feasibility, acceptability, usability, and efficacy of the IVR system from the perspectives of the children, parents and staff. The mixed-method approach (collecting quantitative and qualitative data)
Participants:
Child participants (n=15) will be patients of Sheffield Teaching Hospitals NHS Trust.
Inclusion criteria, aged 11-16.
This study also included parents who have child participating in the study and being able to speak and understand English.; and physiotherapists involved in the physical therapeutic. There are no exclusion criteria for parents or staff, so long as they meet the inclusion criteria.
Masking: None (Open Label)
Primary purpose: Supportive Care