The CloudUPDRS Smartphone Software in Parkinson's Study.

Study Overview
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Brief Summary
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This study compares the validity and usability of smartphone software for home monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical gold standard - the Unified Parkinsons Disease Rating Scale.

Detailed Description
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Parkinson's Disease (PD) is a neurodegenerative condition, which when treated can result in fluctuating motor activity - sometimes too much movement, sometimes too little. A series of tests, run on a smartphone, will be used to evaluate the motor signs of Parkinson's and related to a clinical evaluation based on the Unified Parkinson's Disease Rating Scale. 60 participants will be recruited.

Official Title
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The CloudUPDRS Smartphone Software in Parkinson's Study - a Pilot Dual-site, Open Label Study Comparing the Validity of Smartphone Software for Monitoring the Symptoms and Signs of Parkinson's Disease.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: CloudUPDRS smartphone software assessment
* Other: Clinical assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with probable idiopathic Parkinson's Disease according to Brain Bank criteria (Gibb and Lees, 1988). Over 18 years old. Achieve >20/30 on the Montreal Cognitive Assessment (MOCA). They must have been on the current Parkinson's Disease medication schedule for at least a week and have no plans to change this during the period of testing. They must have the capacity to consent to take part in the study. They must be able to understand English to the level of being able to operate the phone software, follow its instructions and be able to answer the study questions. Exclusion Criteria: Acute medical illness. Any other co-morbidity that in the opinion of the Investigator may preclude their participation in the study. Unable to consent to the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical Assessment<br>Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale. | Other: Clinical assessment<br>* A clinician will assess the motor signs of the participant using the Unified Parkinson's Disease Rating Scale. The examination will be videoed and rated by 3 blinded examiners.<br>|
| Experimental: Smartphone assessment<br>CloudUPDRS smartphone software assessment will be performed. | Device: CloudUPDRS smartphone software assessment<br>* Smartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of smartphone software for home monitoring in Parkinson's disease | The primary objective is to measure the validity (bias and reliability) of the smartphone UPDRS (smartphone derived UPDRS). The primary objective outcome measure is the accuracy (and error) of the smartphone UPDRS predictions of the clinical UPDRS rating score. This will be ascertained by using multiple cross-validation runs in which the data are randomly split into 'calibration' and 'testing' cohorts. The model will be trained on the 'calibration' dataset, and the accuracy and error from the out-of-sample predictions will be summarised into a mean accuracy and error score. | 3 years |