Rehabilitation in Parkinson Disease Cyclone in Life (IRMA)

IR3MA Parkinson Cyclone in Life: Innovation, R3 Rehabilitation - Resonance - RTD Fluxgate Sensor, Multidisciplinary Approach

Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

• Improved joint function and gait pattern
• Reduction of the risk of falling or reduction of energy expenditure during physiological gait

Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Physical Disability
• Intervention / Treatment: Device: IRMA

Detailed Description

rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98124
    • IRCCS Centro Neurolesi "Bonino-Pulejo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hoehn & Yahr between 2.0 and 3.0;
• No need for a walking aid;
• Mini-Mental State Examination (MMSE) score >24;
• Effective dopaminergic pharmacological control;
• Absence of other relevant neurological comorbidities;
• Absence of postural deformities (and/or Pisa syndrome);
• Absence of severe cardiological pathologies (exertional angina, severe decompensation).
• Ability to travel to the rehabilitation treatment site independently or with support

Exclusion Criteria:

• presence of Deep Brain Stimulation (DBS);
• presence of severe heart and/or lung disease;
• presence of therapeutic regimen in the definition phase;
• impaired joint and/or motor function to follow a proposed rehabilitation treatment programme
• contraindications to performing MRI scans
• undergoing rehabilitation therapy in the 3 months preceding enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control GROUP; This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, joint range increase with passive and active assisted mobilization sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing positions with feedback and feed-forward techniques. gait training; gait training; proprioceptive exercises and exercises to maintain static and dynamic balance in monopodalica; strengthening of trunk muscles; postural exercises, muscle relaxation/stretching, release of the tracks; re-education in postural passages and transfers with fall prevention strategies.
Experimental: irma group; This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, increasing joint range with assisted passive and active mobilisation sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing with feedback and feed-forward technique. Gait training; gait training; proprioceptive exercises and static and dynamic balance maintenance in monopodalics; trunk muscle strengthening; postural exercises, muscle relaxation/relaxation, caterpillar release; re-education in postural transitions and transfers with fall prevention strategies. Prior to neuromotor rehabilitation treatment, the subjects will undergo rehabilitation training using the NIRVANA augmentative reality system.	Device: IRMA; For patients in an advanced state of illness, advanced neuromotor rehabilitation treatment included 1) robot therapies, 2) specific water courses (e.g. walking pools, hydrokinesiotherapy pools, etc.), 3) advanced cognitive treatments (e.g. virtual reality courses); 4) augmentative immersive therapy in a virtual environment; 5) courses also dedicated to social reintegration and inclusive activities (theatre-therapy, art-therapy, dance-therapy, agro-therapy, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS)	The Berg Balance Scale is a scale for assessing balance and the risk of falling	8 weeks

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: I.R.M.A.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No