Clinical trial NCT04568447: Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients
Official title: Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: parkinson disease
Imoove
Elispheric movement
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MDS-UPDRS score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: EURO QOL-5D (EQ-5D)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Pisana
Study officials:
affiliation: IRCCS San Raffaele
name: fabrizio stocchi, md phd
role: PRINCIPAL_INVESTIGATOR
References: