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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04568447
Acronym
IMOOVE-PD
Enrollment
23
Registered
2020-09-29
Start date
2019-01-09
Completion date
2021-03-22
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

parkinson disease, Imoove, Elispheric movement

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.

Interventions

DEVICEIMOOVE

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

Sponsors

IRCCS San Raffaele Roma
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MDS-UPDRS scorethrough study completion, an average of 1 yearChange 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

MeasureTime frameDescription
EURO QOL-5D (EQ-5D)through study completion, an average of 1 yearPositive change in the quality of life score between 0-100 (from worst to better quality of life)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026