Rehabilitation in Parkinson Disease Cyclone in Life

NCT05802498 | Completed

• 1 other identifier: I.R.M.A.
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Physical Disability

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  The Berg Balance Scale is a scale for assessing balance and the risk of falling

  8 weeks

Study Arms (2)

control GROUP

NO INTERVENTION

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.

irma group

EXPERIMENTAL

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

Interventions

IRMA DEVICE

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.).

irma group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, 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 Design

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

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 6, 2023
• Study Start: July 21, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 20, 2023
• Last Updated: April 6, 2023

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)