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Completed

NCT Number: NCT05802498

Rehabilitation in Parkinson Disease Cyclone in Life

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.

Completed

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.).

Primary outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

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

Acronym: IRMA

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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