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Improving Walking Ability in Parkinson Disease (PASTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03921697
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : January 31, 2020
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Augusto Fusco, Fondazione Don Carlo Gnocchi Onlus

Brief Summary:
Gait impairments of patients with Parkinson's disease (PD) limit the independence in the daily activities and sensibly increase the risk of falls. New gait analysis methods, based on wearable inertial sensors, have been proposed to track the gait features during treatment and in real-life conditions. Gait training based on auditory cues as Rhythmical Auditory Stimulation (RAS) have preliminarily shown positive effects improving gait velocity, stride length, step cadence of walking in PD. In the current project, the research group will aim to develop a smartphone application (Parkinson App Smartphone Aimed: P.A.St.A.) integrated with sensors and RAS. In a second time, investigators will analyze the spatio-temporal gait parameters obtained by the wearable sensors and the sociodemographic and clinical data, thus generating a big data set, to improve the knowledge about current pharmacological therapies and rehabilitation.

Condition or disease Intervention/treatment
Parkinson Disease Device: Werable sensors

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parkinson App SmarTphone Aimed to Improve Walking Ability and Reduce Fall (P.A.S.T.A.)
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Parkinson Disease Patients

Patients with PD will be recruited at Fondazione Policlinico Universitario Gemelli and Fondazione Don Gnocchi ONLUS in Rome. All included patients will be affected by idiopathic PD. Clinical data will be acquired by a trained neurologist.

We will remotely monitor 300 patients through wearable sensors. Subjects will be instructed to wear the sensor for 14 consecutive days.

Device: Werable sensors
Parkinson Disease Patients monitored by werable sensors

Primary Outcome Measures :
  1. Correlations between inertial sensor-derived measures of motor function and clinician ratings during performance of the UPDRS part 3 and total exam at baseline [ Time Frame: Fourteen days ]
    Features extracted from continuous accelerometer signals recorded during real life for fourteen days, will be correlated with each relevant component of the UPDRS part 3 and corresponding clinician ratings to quantify the relationship between these measures.

Secondary Outcome Measures :
  1. Time Up&Go [ Time Frame: Baseline ]
    Time Up&Go is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD patients will be enrolled among outpatients of the Movement Disorders Unit of the Gemelli University Hospital and outpatients of the Fondazione Don Carlo Gnocchi Onlus.

Inclusion Criteria:

  • Idiopathic Parkinson's disease diagnosed by a neurologist
  • Ability to sign informed consent

Exclusion Criteria:

  • Inability to sign informed consent
  • Inability to fill out questionnaires (i.e. due to poor vision, inability to read, etc)
  • Presence of psychiatric diseases (episode or any form of psychosis, diagnosed by a psychiatrist in the last year).
  • Age under 18 yrs old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03921697

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Contact: Isabella Imbimbo, M.S. +390633086414

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Fondazione Don Carlo Gnocchi Onlus Recruiting
Roma, Italy, 00166
Contact: Isabella Imbimbo    0633086414   
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Catholic University of the Sacred Heart
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Principal Investigator: Augusto Fusco, M.D.; Ph.D. IRCCS Fondazione Don Carlo Gnocchi
Heiderscheit BC. Movement Variability as a Clinical Measure for Locomotion. Journal of Applied Biomechanics 16(4): 419-427, 2000.

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Responsible Party: Augusto Fusco, Principal Investigator; M.D.; Ph.D., Fondazione Don Carlo Gnocchi Onlus Identifier: NCT03921697    
Other Study ID Numbers: GR-2016-02362879
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Augusto Fusco, Fondazione Don Carlo Gnocchi Onlus:
Technological Rehabilitation; Digital Inclusion
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases