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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: IMOOVE

• Registration Number: NCT04568447
• Lead Sponsor: IRCCS San Raffaele Roma

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.

Study Timeline

• Study Start: 2019-01-09
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Primary Completion: 2021-03-22
• Study Completion: 2021-03-22
• Status Verified: 2022-10
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
MDS-UPDRS score	through study completion, an average of 1 year	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

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

Trial Locations

Locations (1)

IRCCS San Raffaele Pisana; 🇮🇹 Rome, Italy