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

NCT04568447 | Completed DMC

• 1 other identifier: RP 36/18
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

parkinson disease; Imoove; Elispheric movement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• EURO QOL-5D (EQ-5D)

  through study completion, an average of 1 year

Study Arms (1)

IMOOVE

EXPERIMENTAL

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

Device: IMOOVE

Interventions

IMOOVE DEVICE

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

IMOOVE

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Parkinson's Disease (diagnosed according to UK Brain Bank Criteria);
• Age: 40-80

You may not qualify if:

• All the usual contraindications associated with physical medicine, rehabilitation and sport

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele Pisana

Rome, 00166, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• fabrizio stocchi, md phd

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: January 9, 2019
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: April 10, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the end of study
• Access Criteria: request by email

Locations

IT (1)