Using Immersive Virtual Reality for Children's Lower Limb Rehabilitation

NCT05274152 | Completed

• 1 other identifier: AA14737018
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Virtual Reality; Physical Rehabilitation; Lower Limb Injury; Paediatric

Outcome Measures

Primary Outcomes (5)

• Ratings of child participant's pre physiotherapy anxiety

  Child participant complete the Generalised Anxiety Disorder Assessment (GAD-7) scale measure in the data collection booklet in clinic The GAD-7 originates from Spitzer RL, Kroenke K, Williams JB, et al; A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. GAD-7 © Pfizer Inc. all rights reserved; used with permission. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

  3-5 days

• Ratings of child participant's movement during physiotherapy sessions: Goniometer (Standard BASELINE® 12-inch)

  Goniometer device (Standard BASELINE® 12-inch plastic goniometer, (Model 12-1000-Fabrication Enter- prises, Inc: White Plains, New York) was used by the clinical staff before and after the patient's rehabilitation to document the initial and subsequent range of motion, evaluate their progress and to determine the level of disability. We used the goniometer, to assess the physical therapy effectiveness of the VR rehabilitation and to personalize the system's range of motion for each patient. We examined the differences between a range of movements limb join (flexion, extension, abduction, and adduction) before and after the VR rehabilitation. The greater the range of movement the better.

  3-5 days

• Ratings pain of child participant's post physiotherapy

  Child participant will complete the The visual analog scale (VAS) scale measure in the data collection booklet in clinic. The VAS is a validated, subjective measure for acute and chronic pain. Scores rom 0-100 are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). \*Delgado, D. A., Lambert, B. S., Boutris, N., McCulloch, P. C., Robbins, A. B., Moreno, M. R., \& Harris, J. D. (2018). Validation of digital visual analog scale pain scor

  3-5 days

• Interviews with child and parent participant

  Semi-structured interviews were conducted by the research by zoom with patients and parents after the IVR rehabilitation at-home trial. Four closed ten-point Likert questions provided a quantitative measure of the perceived ease or difficulty of use, pain levels and enjoyability of the IVR system. Open-ended questions provided qualitative data relating to difficulty, pain and enjoyability, and participant attitudes towards the IVR system and its future deployment. Another semi-structured interview was conducted with the OT by the research nurse in person at the end of the trial to explore her attitudes towards the IVR system and future VR deployment. Both interviews were recorded, transcribed and anonymised.

  3-5 days

• System Usability Scale (SUS) results

  System Usability Scale SUS) is a quantitative scale to measure system usability was completed by patients after the IVR rehabilitation at-home trial. It consists of a 10 item with 5-point response options from Strongly agree to Strongly disagree (Brooke, 1996). The scale evaluates the perceived ease of use (a single dimension). However, recent research shows that items 4 and 10 could provide the learnability dimension. Score contribution of each item was coded from 0 to 4 (items with positive words 1, 3, 5, 7 and 9; items with negative words 2, 4, 6, 8 and 10), and the sum of the contributions of the item scores was multiplied by 2.5 to obtain the overall SUS score (0 to 100). Scores were analysed above or below the standard mean score of 68. A score close to 100 was considered good usability of the system.

  3-5 days

Study Arms (2)

Patients IVR for Lower Limb and Knee Rehabilitation after surgery in children

EXPERIMENTAL

Patients will 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.

Device: Immersive Virtual Reality Lower Limb and Knee Rehabilitation

Occupational Therapist perceptions of the effectiveness of the IVR

OTHER

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.

Device: Immersive Virtual Reality Lower Limb and Knee Rehabilitation

Interventions

Immersive Virtual Reality Lower Limb and Knee Rehabilitation DEVICE

Patients wore a VR headset while undergoing their rehabilitation session

Occupational Therapist perceptions of the effectiveness of the IVR; Patients IVR for Lower Limb and Knee Rehabilitation after surgery in children

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged 11-16.
• able to speak and understand English.
• receiving physiotherapy rehabilitation treatment as an inpatient following lower limb or knee surgery, in order to restore or improve movement and function.

You may not qualify if:

• \- Injuries to the face or head that could hinder the correct positioning of the headset or pose an infection risk
• A learning impairment that could hinder the understanding of the task
• A history of severe motion sickness or vertigo.
• Mental health problems
• In order to avoid unnecessary psychological or physical distress, it is expected that we will exclude those with acute mental health symptoms as assessed by clinicians, where the use of VR might be contraindicated.
• Children with mild, well controlled mental health problems will not be excluded from the study, as long as parents, child, and clinicians are in agreement. VR can occasionally cause dizziness or nausea in individuals with motion sickness, and although designed to be as enjoyable as possible, activities in the VR may cause anxiety in those with vertigo. These issues will be identified in the information sheets and discussed with parents.

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Ivan Phelan

Sheffield, South Yorkshire, S1 2NU, United Kingdom

Location

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ivan Phelan

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: December 12, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)