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The CloudUPDRS Smartphone Software in Parkinson's Study.

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02937324
Acronym
CUSSP
Enrollment
60
Registered
2016-10-18
Start date
2016-09-30
Completion date
2019-09-30
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

DEVICECloudUPDRS smartphone software assessment

Smartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS.

OTHERClinical assessment

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.

Sponsors

University College, London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Validity of smartphone software for home monitoring in Parkinson's disease3 yearsThe 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.

Other

MeasureTime frameDescription
Data exploration3yearsData from this study will be subjected to post hoc analysis to explore future hypotheses in this area.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026