Intensive Multidisciplinary Rehabilitation and Biomarkers in Parkinson's Disease

Summary

Parkinson's disease (PD) is a progressive neurological disorder characterized by motor and non-motor symptoms such as rigidity, bradykinesia, resting tremor, cognitive and autonomic dysfunctions, gait and balance difficulties.

The impairment of gait, balance and cognitive performances is partially responsive to dopaminergic medications. This emphasizes the importance of non-pharmacological interventions for people with PD (pwPD).

Intensive multidisciplinary motor and cognitive rehabilitation has been proposed as a complementary and effective treatment for managing pwPD.

Several structural and physiological mechanisms have been suggested to underpin exercise-induced neuroplastic changes in PD, such as enhanced synaptic strength and preservation of dopamine neurons. To date, studies on brain changes induced by motor and cognitive exercises in pwPD have been small-scaled and uncontrolled.

Identifying accessible and measurable biomarkers for monitoring the events induced by intensive motor and cognitive rehabilitation program would help in testing the treatment effectiveness and would allow personalization of rehabilitation strategies by predicting patients' responsiveness.

Based on validated clinical assessments of intensive multidisciplinary rehabilitation treatment, the project will test the ability of a new set of biomarkers to evaluate rehabilitative outcomes in a cohort of people with PD.

Conditions

• Parkinson Disease
• Biomarkers
• Rehabilitation Outcome
• Gait Disorders, Neurologic
• Parkinsonian Disorders
• Basal Ganglia Diseases
• Central Nervous System Diseases
• Movement Disorders
• Synucleinopathies
• Neurodegenerative Diseases
• Cognitive Impairment
• Gait Analysis
• Pathologic Processes
• Magnetic Resonance Imaging
• Physiotherapy

Interventions

BEHAVIORAL

Multidisciplinary Intensive Rehabilitation

The rehabilitation program will last for 6 consecutive weeks and involves the execution of 30 sessions, 5 days a week lasting 160 '/ day each (80' motor; 40 'cognitive and 40' speech therapy rehabilitation) for 3 days a week and 180'/ day (80 'motor; 60' cognitive and 40 'speech therapy rehabilitation) for 2 days a week. The EXP group will receive 18 sessions (3 times a week) of treadmill (20 min), balance exercises and functional reinforcement (20 min). The remaining motor sessions will be defined based on the patient's therapeutic needs. The cognitive treatment will be proposed both in traditional mode (3 times a week) and through the support of semi-immersive "Virtual Reality Rehabilitation System" (VRRS) (2 times/week). The VRRS treatment is structured in 2 sessions per week (60 min) for 6 consecutive weeks. The speech therapy program will include clinical and instrumental evaluations and innovative techniques will be used for the treatment (biofeedback with Vitalstim).

BEHAVIORAL

Muscle-stretching and active mobilization exercises

The control group subjects will undergo a home-based self-treatment program for 40 '/ day for 6 consecutive weeks consisting of muscle-stretching and active mobilization exercises.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Mario Meloni, MD;PhD · IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-09

Primary Completion

2023-09-30

Completion

2023-12-31

Countries

• Italy

Study Locations