IRMA: Rehabilitation in Parkinson Disease Cyclone in Life

Sponsor

IRCCS Centro Neurolesi "Bonino-Pulejo" (Other)

Overall Status

Completed

CT.gov ID

NCT05802498

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Physical Disability	Device: IRMA	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 21, 2020

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 20, 2023

Arms and Interventions

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.).

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.).

Outcome Measures

Primary Outcome Measures

Berg Balance Scale (BBS) [8 weeks]
The Berg Balance Scale is a scale for assessing balance and the risk of falling

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Centro Neurolesi "Bonino-Pulejo"	Messina		Italy	98124

Sponsors and Collaborators

IRCCS Centro Neurolesi "Bonino-Pulejo"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRCCS Centro Neurolesi "Bonino-Pulejo"

ClinicalTrials.gov Identifier:

NCT05802498

Other Study ID Numbers:

I.R.M.A.

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Apr 6, 2023