Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Rehabilitation

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Riccardo Buraschi, PT; Phone Number: 282 00390307245; Email: rburaschi@dongnocchi.it

Study Locations

• Italy
  • BS
    • Rovato, BS, Italy, 25038
      • Recruiting
      • Fondazione Don Carlo Gnocchi
      • Contact: Riccardo Buraschi; Phone Number: 282 0307245; Email: rburaschi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population of subjects affected by Parkinson Disease

Description

Inclusion Criteria:

• Subjects with Idiopathic Parkinson's Disease;
• Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
• Subjects must be able to walk at least 10 meters independently with or without any walking aid

Exclusion Criteria:

• Non-clinically stable subjects;
• Subjects in OFF phase during the evaluations;
• Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
• Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson Disease; Rehabilitation according to Physiotherapy and Occupational Therapy European Guidelines for Parkinson Disease.	Other: Rehabilitation; Intervention focused on balance, gait and postural transfers rehabilitation. 20 session of 90 minutes (60 minutes of physiotherapy and 30 minutes of occupational therapy), 2 times a week, for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in execution time of Postural Transfers	The execution time is measured via an inertial measurement unit attached to the back of the patient	Change from Baseline at 10 weeks
Change of execution velocity of Postural Transfers	The execution velocity is measured via an inertial measurement unit attached to the back of the patient. Specifically the velocity are measured as the Root Mean Square of gyroscope signal.	Change from Baseline at 10 weeks
Change of antero-posterior acceleration during Postural Transfers execution	The antero-posterior acceleration is measured via an inertial measurement unit attached to the back of the patient.	Change from Baseline at 10 weeks
Change of superior-inferior acceleration during Postural Transfers execution	The superior inferior acceleration is measured via an inertial measurement unit attached to the back of the patient.	Change from Baseline at 10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Time Up and Go Test	Change from baseline at 10 weeks
Change in 10 meter walking test	Change from baseline at 10 weeks
Change in Berg Balance Scale Score	Change from baseline at 10 weeks
Change in Short-Form 12 score	Change from baseline at 10 weeks

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Principal Investigator: Riccardo Buraschi, PT, Irccs Fondazione Don Carlo Gnocchi

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Parkinson Disease; Postural Transfers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: FDG_PosTrans

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No