The CloudUPDRS Smartphone Software in Parkinson's Study.

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Device: CloudUPDRS smartphone software assessment; Other: Clinical assessment

• Registration Number: NCT02937324
• Lead Sponsor: University College, London

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Status Verified: 2018-07
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosed with probable idiopathic Parkinson's Disease according to Brain Bank criteria (Gibb and Lees, 1988).
2. Over 18 years old.
3. Achieve >20/30 on the Montreal Cognitive Assessment (MOCA).
4. 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.
5. They must have the capacity to consent to take part in the study.
6. 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

1. Acute medical illness.
2. Any other co-morbidity that in the opinion of the Investigator may preclude their participation in the study.
3. Unable to consent to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Smartphone assessment	CloudUPDRS smartphone software assessment	CloudUPDRS smartphone software assessment will be performed.
Clinical Assessment	Clinical assessment	Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale.

Primary Outcome Measures

Name	Time	Method
Validity of smartphone software for home monitoring in Parkinson's disease	3 years	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.

Trial Locations

Locations (1)

Ashwani Jha; 🇬🇧 London, United Kingdom