Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients (IMOOVE-PD)

Parkinson's Disease (PD) is one of the most frequent causes of motor dysfunction in aging.

It is therefore important to use rehabilitative therapeutic approaches that may prevent the development of motor complications when possible.

Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.

The project is focused on quantifying the efficacy of IMOOVE® as a treatment method for improving joint mobility, posture and autonomy in PD.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: IMOOVE

Detailed Description

The pathogenesis of PD-related postural abnormalities is probably multifactorial as well as widely indefinite, and this could compromise treatment choices and efficacy. In addition to dystonia and rigidity, proprioceptive and sensorimotor disintegration as well as peripheral degenerative processes (myopathy, skeletal and soft tissue changes) have been proposed as causative factors of abnormal trunk postures.

When the body is educated in the Elispheric® movement it relearns the original vertebral motion, and postural control necessary for any action by the body, the professional can then perform effective vertebral reeducation.

The Elispheric® movements are created by a motorised plate. This unique technology impulses the body through a centrifugal force in three planes. This force trains the body in its natural spirals.

The performance result is based on the fact that Imoove restores the all freedom of movement, strength, precision and it works on the basic skeletal posture.

It is an exploratory study, in order to verify if the project is adequate, to establish its feasibility and to obtain information that allows to determine the size of the sample of the definitive study, 30 consecutive PD outpatients will be recruited for the IMOOVE® treatment.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00166
    • IRCCS San Raffaele Pisana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with Parkinson's Disease (diagnosed according to UK Brain Bank Criteria);
• Age: 40-80
• Medical treatment for Parkinson's Disease must be stable for at least two weeks prior to inclusion, and during the study. During the study, the dosage of anti-parkinsonian drug treatment should not change, if it is not deemed necessary by the investigator.-

Exclusion Criteria:

• All the usual contraindications associated with physical medicine, rehabilitation and sport

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMOOVE; Patients will undergo IMOOVE® treatment for 6 weeks, two times per week for a total of 12 treatments.	Device: IMOOVE; Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MDS-UPDRS score	Change in the motor symptoms evaluated with the Movement Disorder Society Unified Parkinson's Disease Rating scale (MDS-UPDRS). Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EURO QOL-5D (EQ-5D)	Positive change in the quality of life score between 0-100 (from worst to better quality of life)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Investigators: Principal Investigator: fabrizio stocchi, md phd, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 22, 2021

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: parkinson disease; Imoove; Elispheric movement
• 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: RP 36/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after the end of study
• IPD Sharing Time Frame: after the end of study
• IPD Sharing Access Criteria: request by email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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