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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06256107
Other study ID # 274505
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 13, 2021
Est. completion date October 31, 2023

Study information

Verified date February 2024
Source Lancashire Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Motor Neurone Disease (MND) is a chronic progressive neurological condition where people experience weakness of muscles leading to pain and restriction of movement as well as problems with swallowing, breathing and communication. The purpose of this study is to establish if Virtual Reality is useful for people with MND and if it helps improve their well being.


Description:

Motor Neurone Disease (MND) is a chronic progressive neurological condition where people experience weakness of muscles leading to pain and restriction of movement as well as problems with swallowing, breathing and communication. As people become increasingly immobile, they become restricted in their ability to perform activities of daily living, access the outdoors, participate in preferred occupational roles or engage in leisure activities. Consequently, there is a deterioration in their ability to experience well being and have quality of life. There is also a significant carer burden as the carer spends long hours in the day looking after the person. The average disease trajectory lasts between 3-5 years, followed by death. More recently, the use of Virtual Reality (VR) technology is being recognised in the field of health. This technology uses the interactions between an individual and a computer generated environment to stimulate different sensory modalities such as visual and auditory. The technology can be accessed commonly using head mounted goggles or head sets. The entertaining or stimulating effect of VR is useful in redirecting the person's attention away from the distressing experiences, such as pain and anxiety. The purpose of this study is to establish if VR is useful for people with MND and if it helps improve their well being.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Diagnosis of MND 2. Sufficient cognitive ability to understand instructions with regards using the VR kit (ECAS score - minimum 100/136) 3. Has sufficient motor ability/dexterity to use the kit or a carer who will be able to assist with the use of the kit. 4. Can tolerate light and have sufficient head control to wear the head set. 5. English speaking Exclusion Criteria: 1. Poor cognition - inability to understand instructions regarding the use of VR (Total ECAS Score <100/136) 2. Unable to tolerate light/unable to wear the head set 3. Light sensitive epilepsy, severe vertigo or dizziness. 4. Non English speaking

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual Reality Headset
Virtual Reality Headset

Locations

Country Name City State
United Kingdom Lancashire Teaching Hospitals NHS Foundation Trust Preston

Sponsors (1)

Lead Sponsor Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Edinburgh Mental Well being Scale Quality of Life (Scale 0-10 higher being better) 4 weeks
Secondary ECAS (Edinburgh Cognition Assessment Scale) Cognition measure scale varied per question (Scale 0-8, 0-10, 0-12 higher being better) 4 weeks
Secondary PHQ-9 scale for depression (Scale 0-27 - higher being worse) 4 weeks
Secondary GAD-7 scale for anxiety (Scale 0-3 where higher is worse outcome) 4 weeks
Secondary ALS-FRS test of function (Yes or No - ability to perform function) 4 weeks
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