Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430151
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-16
Brief Title:
Useability and Acceptability of the CUE1 Device in Older People With Parkinsons Disease
Sponsor:
Dr Alistair Mackett
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
Useability and Acceptability of the CUE1 Device in Older People With Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The CUE1 device is a non-invasive wearable device for people with Parkinsons Disease PD approved for sale in the UK The CUE1 device utilises two established methods to improve motor symptoms in PD namely pulsed cueing and vibrotactile stimulation Many people with PD wish to explore non-pharmacological interventions as an adjunct to manage their motor symptom
Study design and eligibility This feasibility study is to establish whether the CUE1 device is a useable and acceptable device for older people with PD 20-25 participants aged 60 years with PD will be recruited from a movement disorder service to the study
Methodology Participants will undertake baseline assessments of motor symptoms and quality of life with a PD nurse assessor in their own home Following this the CUE1 device will be fitted and repeat assessments of motor symptoms will take place after 20 minutes The participants will complete a daily diary of useability and acceptability for 4 weeks A second visit will occur at 4 weeks with the same PD nurse assessor where the final set of motor symptom and quality of life assessments will be completed
Study design and eligibility This feasibility study is to establish whether the CUE1 device is a useable and acceptable device for older people with PD 20-25 participants aged 60 years with PD will be recruited from a movement disorder service to the study
Methodology Participants will undertake baseline assessments of motor symptoms and quality of life with a PD nurse assessor in their own home Following this the CUE1 device will be fitted and repeat assessments of motor symptoms will take place after 20 minutes The participants will complete a daily diary of useability and acceptability for 4 weeks A second visit will occur at 4 weeks with the same PD nurse assessor where the final set of motor symptom and quality of life assessments will be completed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None