The CloudUPDRS Smartphone Software in Parkinson's Study.

NCT ID: NCT02937324

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-09-30

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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clinical Assessment

Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale.

Group Type ACTIVE_COMPARATOR

Clinical assessment

Intervention Type OTHER

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.

Smartphone assessment

CloudUPDRS smartphone software assessment will be performed.

Group Type EXPERIMENTAL

CloudUPDRS smartphone software assessment

Intervention Type DEVICE

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

Interventions

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CloudUPDRS smartphone software assessment

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

Intervention Type DEVICE

Clinical 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kailash Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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Ashwani Jha

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16/0062

Identifier Type: -

Identifier Source: org_study_id

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