Clinical trial NCT05272436: Using Virtual Reality for Rehabilitation of Upper Limbs at Home Trial
Official title: Home-based Immersive Virtual Reality Physical Rehabilitation in Paediatric Patients for Upper Limb Motor Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Injury
Virtual Reality
Rehabilitation
Paediatric
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Sheffield Children's NHS Foundation Trust
First posted: 2022-03-09
Enrollment: 8
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study aimed to explore:

* patients, clinicians, family members perceptions of the effect of IVR on ULMI rehabilitation (range of movement (ROM) recovery)
* patient perceptions of the usability, quality of live, acceptability, engagement with and enjoyment of IVR scenarios;
* occupational therapies perceptions about the usability and implications of the IVR technology within a patient rehabilitation at home.

Methods: This was a small-scale mixed methods (quantitative and qualitative) study.

Patients: paediatric patients recruited from Sheffield Children's Foundation Hospital Trust in England, UK, their parents, and an occupational therapist (OT) from the Sheffield Children's Foundation Hospital Trust for Burns, Plastics, and Orthopaedics participated in the study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The IVR games have been enhanced to include more levels. The new aspects to be tested in this study are new IVR exercises that would be made upper limb rehab designed for children for home use, as repeated sessions with progression through different levels could improve the prospect of good functional recovery. A new wireless headset has recently become available, which will enable the IVR to be run without the need for separate equipment, thereby making home use possible as no complicated set-up will be required.

This project aims to explore the feasibility, acceptability and perceived effectiveness of an improved suite of Immersive Virtual Reality (IVR) system suitable for Upper Limb Motor Impairment (ULMI) rehabilitation for children at home. A multidirectional perspective has been adopted, including patients, caregivers, and clinical staff.

The aims and objectives of the clinical feasibility trial are:

* to investigate the potential of IVR for ULMI rehabilitation (range of motion recovery) at home compared to usual physical therapy in a small sample of paediatric patients.
* to measure the impact of the interventions from a mixed methods (quantitative and qualitative) and a multidirectional perspective (patients, clinicians, family members).

Detailed description: This project builds upon a previous MRC 'Confidence in Concept' feasibility project which developed Virtual Reality (VR) games for participants at Sheffield Children's Hospital to do arm rehabilitation movements such that they become so engrossed in the IVR they become much less aware of any pain or discomfort linked to the exercises.

Patients (and carer where appropriate) would be involved in the design of the scenarios, the protocol, patient information sheets, and the project steering group. Research nurses will download anonymised usage data from the VR headset used at home and interview participants. All data will feed into an evaluation which will demonstrate the concept and acceptability of using IVR at home.

Procedure Patients usually have a 20-30 minutes appointment during which the OT/PT reviews their previously prescribed home exercise regime with them, measures ROM, and explains and discusses new home exercises. For the purpose of the trial, patients had their usual OT/PT appointments but were asked to use the IVR games to do the prescribed home exercises. Before consenting to participate, each patient was offered a 5-10 minute experience of the game to familiarise themselves with how it worked and to check for problems. Written and verbal consents were taken from parents and children.

The pre-trial PedsQL was administered in the initial OT/PT appointment. Children were then asked to use the IVR system for approximately 15 minutes twice a day. Trial participation lasted three weeks during the prescribed treatment weeks.

Following the at-home trial, patients and parents returned the equipment to the clinic in the final appointment and the SUS and the post-trial Peds QL were administrated by OT/PT in person. In addition, they participated in semi-structured interviews as described above.

At the end of the trial, an interview (10 minutes) with the OT was conducted by a research nurse.

Eligibility criteria: Inclusion Criteria:

* aged 7-16
* upper limb injuries, for which they are receiving rehabilitative care
* able to speak and understand English.

Exclusion Criteria:

1. injuries to the face or head that could hinder the correct positioning of the headset or pose an infection risk;
2. A learning impairment that could hinder the understanding of the task;
3. A history of severe motion sickness;
4. Mental health problems;
5. Inability to speak and understand English.

Primary outcomes:
measure: Ratings of child participant's movement during physiotherapy sessions: Goniometer (Standard BASELINE® 12-inch)
timeFrame: Three weeks
measure: Paediatric Quality of Life Inventory (PedsQL) (Version 4.0 - UK English) results
timeFrame: Three weeks
measure: System Usability Scale (SUS) results
timeFrame: Three weeks
measure: Interview Qualitative Results, Perceptions, Usability and Effectiveness of IVR system in ULMI rehab in children at home
timeFrame: Three weeks
measure: Interview Quantitative Results, Perceptions, Usability and Effectiveness of IVR system in ULMI rehab in children at home
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Ivan Phelan
state: South Yorkshire
Study officials:
References: