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

Parkinson Disease Clinical Trial

— IMOOVE-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568447
• Other study ID #: RP 36/18
• Status: Completed
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: March 22, 2021

Study information

• Verified date: October 2022
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Pisana	Rome

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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