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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IMOOVE
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson disease, Imoove, Elispheric movement

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS San Raffaele Pisana

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMOOVE

Arm Description

Patients will undergo IMOOVE® treatment for 6 weeks, two times per week for a total of 12 treatments.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

EURO QOL-5D (EQ-5D)
Positive change in the quality of life score between 0-100 (from worst to better quality of life)

Full Information

First Posted
September 23, 2020
Last Updated
October 17, 2022
Sponsor
IRCCS San Raffaele Roma
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1. Study Identification

Unique Protocol Identification Number
NCT04568447
Brief Title
Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients
Acronym
IMOOVE-PD
Official Title
Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele Roma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson disease, Imoove, Elispheric movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMOOVE
Arm Type
Experimental
Arm Description
Patients will undergo IMOOVE® treatment for 6 weeks, two times per week for a total of 12 treatments.
Intervention Type
Device
Intervention Name(s)
IMOOVE
Intervention Description
Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.
Primary Outcome Measure Information:
Title
MDS-UPDRS score
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
EURO QOL-5D (EQ-5D)
Description
Positive change in the quality of life score between 0-100 (from worst to better quality of life)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fabrizio stocchi, md phd
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Raffaele Pisana
City
Rome
ZIP/Postal Code
00166
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
after the end of study
IPD Sharing Time Frame
after the end of study
IPD Sharing Access Criteria
request by email

Learn more about this trial

Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients

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