Status:

COMPLETED

Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease

Lead Sponsor:

Prof. Massimo Filippi

Conditions:

Parkinson Disease

Eligibility:

All Genders

Up to 85 years

Phase:

NA

Brief Summary

The aim of this study is to assess the effect of 8-week physiotherapy training using immersive virtual reality (VR-training) compared to a physiotherapy training performed in a real setting (RS-traini...

Eligibility Criteria

Inclusion

  • Inclusion criteria for PD patients:
  • Diagnosis of idiopathic Parkinson's disease
  • H\&Y scale ≤ 3 while on medication
  • Age ≤ 85 years
  • Right-handedness with the Edinburgh Handedness Inventory Quotient
  • Right-side involvement according to H\&Y and Movement Disorder Society Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III)
  • Handwriting difficulty defined by a score greater than or equal to 1 on item II.7 of the MDS-UPDRS
  • Oral and written informed consent to study participation
  • Inclusion criteria for healthy controls:
  • Sex-matched and age-matched with PD patients;
  • Right-handed;
  • Oral and written informed consent to study participation.
  • Exclusion criteria for PD patients:
  • Mini-Mental State Examination lower than 24;
  • Visual impairments that interfere with the immersive virtual environment;
  • (Other) upper limb deficits impeding handwriting;
  • History of (other) systemic, neurologic, psychiatric diseases, head injury and cerebrovascular alterations visible at an MRI scan;
  • Family history of neurodegenerative disorders;
  • History of alcohol and/or psychotropic drug abuse;
  • Contraindications for MRI;
  • Denied oral and written informed consent to study participation.
  • Exclusion criteria for healthy controls:
  • Mini-Mental State Examination lower than 28;
  • Visual impairments that interfere with the immersive virtual environment;
  • History of systemic, neurologic, psychiatric diseases, head injury and cerebrovascular alterations visible at an MRI scan;
  • History of alcohol and/or psychotropic drug abuse;
  • Contraindications for MRI;
  • Denied oral and written informed consent to study participation

Exclusion

    Key Trial Info

    Start Date :

    May 17 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 6 2024

    Estimated Enrollment :

    70 Patients enrolled

    Trial Details

    Trial ID

    NCT04876352

    Start Date

    May 17 2021

    End Date

    September 6 2024

    Last Update

    April 8 2025

    Active Locations (1)

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    IRCCS San Raffaele

    Milan, Italy, 20132

    Virtual-reality for Upper Limb Rehabilitation in People With Parkinson's Disease | DecenTrialz