Actively Recruiting

Phase Not Applicable
Age: 60Years - 100Years
All Genders
NCT06430151

Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease

Led by Dr Alistair Mackett · Updated on 2024-05-28

20

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The CUE1 device is a non-invasive wearable device for people with Parkinson's 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.

CONDITIONS

Official Title

Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease

Who Can Participate

Age: 60Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals under the care of a Cambridge University Hospitals Foundation Trust movement disorder service with an established clinical diagnosis of Parkinson's disease based on the UK Brain bank criteria
  • Age between 60 and 100 years
Not Eligible

You will not qualify if you...

  • Co-existing significant neurological disorders such as disabling stroke, multiple sclerosis, dementia, or motor neurone disease
  • Diagnosis of atypical parkinsonian disorders like multiple systems atrophy, progressive supranuclear palsy, or cortical basal degeneration syndrome
  • Physical impairments causing significant mobility issues, including severe lower limb osteoarthritis
  • Trauma or pain to the sternum
  • Use of other medical devices such as pacemakers, deep brain stimulators, or TENS machines
  • Lack of capacity to consent to the study
  • Sensitivity to medical adhesives
  • Current participation in another intervention research trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cambridge University Hospitals Foundation Trust

Cambridge, United Kingdom

Actively Recruiting

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Research Team

A

Alistair J Mackett, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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