Rehabilitation in Parkinson Disease Cyclone in Life

Not Applicable

Completed

• Conditions: Parkinson Disease; Physical Disability

• Registration Number: NCT05802498
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

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 Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-21
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-20
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"; 🇮🇹 Messina, Italy