Rehabilitation in Parkinson Disease Cyclone in Life

Parkinson Disease Clinical Trial

— IRMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802498
• Other study ID #: I.R.M.A.
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: January 20, 2023

Study information

• Verified date: July 2020
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 20, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Physical Disability

Intervention

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.).

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi "Bonino-Pulejo"	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale (BBS)	The Berg Balance Scale is a scale for assessing balance and the risk of falling	8 weeks