Using Virtual Reality for Rehabilitation of Upper Limbs at Home Trial

NCT ID: NCT05272436

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-06-06

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.

Conditions

Upper Limb Injury; Virtual Reality; Rehabilitation; Paediatric

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients IVR for Upper Limb Motor Impairment Rehabilitation in children and at home trial

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.

Group Type: EXPERIMENTAL

Virtual Reality Upper Limb Motor Impairment Rehabilitation

Intervention Type: DEVICE

Patients wore a VR headset while undergoing their physical rehabilitation at home

Occupational Therapist perceptions of the effectiveness of the IVR

She recruited the patients, gave out devices, administered the outcome measures and provided us with feedback about their experience with the VR game.

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

Group Type: OTHER

Virtual Reality Upper Limb Motor Impairment Rehabilitation

Intervention Type: DEVICE

Patients wore a VR headset while undergoing their physical rehabilitation at home

Interventions

Virtual Reality Upper Limb Motor Impairment Rehabilitation

Patients wore a VR headset while undergoing their physical rehabilitation at home

Intervention Type: DEVICE

Other Intervention Names

No intervention

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Sheffield Hallam University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ivan Phelan

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

Phelan I, Carrion-Plaza A, Furness PJ, Dimitri P. Home-based immersive virtual reality physical rehabilitation in paediatric patients for upper limb motor impairment: a feasibility study. Virtual Real. 2023 Jan 14;27(4):1-16. doi: 10.1007/s10055-023-00747-6. Online ahead of print.

Reference Type: DERIVED

PMID: 36686613 (View on PubMed)

Other Identifiers

AA14673868

Identifier Type: -

Identifier Source: org_study_id