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Completed

NCT Number: NCT04568447

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Pisana

Rome, 00166, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMOOVE

Device

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

Primary outcomes

  1. MDS-UPDRS score

    Time frame: 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 outcomes

  1. EURO QOL-5D (EQ-5D)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Acronym: IMOOVE-PD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2020
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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