Immersive Virtual Reality for Dysphagia

NCT06325579 | Completed

• 1 other identifier: AA29411356
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology.

Conditions

Virtual Reality; Dysphagia; Treatment Compliance

Outcome Measures

Primary Outcomes (2)

• Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes.

  After the trial to obtain feedback from the patients and speech therapist assistant in the clinical trial, semi structured interviews were use. Questions were focus on their experience of the headset, strain gauge and IVR intervention, and their experiences and perceptions of swallowing whilst playing. Staff questions were focus on her experience of using the IVR with the patient, their perceptions of its effectiveness, usability, potential and limitations. Qualitative data was gathered from patient and staff interviews. A qualitative content analysis was conducted to identify the key experiential and perceptual findings.

  10 to 40 minutes interviews

• Feasibility of the system. Semi-structure Interviews with patients. Quantitative outcomes.

  The interview will have ten question of liker scales eleven (0-10) answer rate (eg. How comfortable was it to wear the VR headset?; 2. How comfortable was it to wear the strain gauge?). Descriptive statistical analyses were conducted using SPSS statistical package.

  10 to 40 minutes interviews

Study Arms (1)

Dysphagia patients using VR

EXPERIMENTAL

Day 1: Consent taken 5mins. Baseline period wearing strain gauge 5mins, it´d pick up and measure the patient's swallow movements while at rest not using the VR. IVR trial 25mins, the headset will be refitted and instructions to use two different games for up to 10 minutes with a 5-minute break in between. The SALT Assistant would be closely guide and monitor the participant. The experience will be concluded for the day if the participant shows sign of or indicates discomfort. Days 2-4 (30-35mins) same proceed as above, minus the test experience (Baseline period (5 mins) and IVR trial (25 mins). Day 5 (40-45mins) final day of the trial and after take part in a short semi-structured interview (10mins) in person and audio recorded by the SALT Assistant. SALT Assistant post-trial interview (25-40mins) online audio recorded by a member of the research team .

Device: Immersive Virtual Reality for Dysphagia Treatment

Interventions

Immersive Virtual Reality for Dysphagia Treatment DEVICE

Patients wore a VR headset while undergoing their rehabilitation session

Dysphagia patients using VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The target sample for the clinical feasibility trial is 10 adult (aged 18+) stroke in-patients receiving care at the Stroke.
• Pathway Assessment and Rehabilitation Centre (SPARC) in at STH during the recruitment period of the study.

You may not qualify if:

• A severe language, communication or cognitive impairment preventing full consent or engagement.
• Hemianopia preventing stereoscopic vision.
• Severe mental health issues which could give rise to unnecessary. psychological or physical distress during IVR use.
• Head or neck injuries which would prevent participants wearing the IVR headset and strain gauge around the neck.
• A history of severe motion sickness since, since IVR can occasionally stimulate motion sickness in those already strongly affected by these symptoms.
• The two members of staff involved in delivering the intervention will also take part in interviews following completion of the study.

Sponsors & Collaborators

• Sheffield Hallam University: lead

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, S1 2NU, United Kingdom

Location

MeSH Terms

Conditions

Deglutition Disorders; Patient Compliance

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ivan Phelan, MSc

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 22, 2024
• Study Start: May 24, 2021
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)