A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease

A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease: a Randomized Pilot Study

We investigate the impact of a 4-week virtual reality-based upper limb training in Parkinson's disease. The benefits on dexterity of this training program will be evaluated.

For these purposes, a randomised, two arm, single assessor blind, parallel design with a monocentric, study setup will be performed.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: virtual reality upper limb hand training; Other: virtual reality control training

Detailed Description

Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore the effects of a VR-based upper limb hand training compared to a VR control training, which is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper limb related ADL, and therefore the impact on QoL in patients with PD.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cornelia Cox, MSc; Phone Number: 041 205 56 80; Email: cornelia.cox@luks.ch
• Study Contact Backup: Name: Manuela Pastore, PhD; Phone Number: 041 205 72 20; Email: manuela.pastore@luks.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6000
    • Recruiting
    • Luzerner Kantonsspital
    • Contact: Manuela Pastore, PhD; Phone Number: 0412057220; Email: manuela.pastore@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with confirmed PD, according to UK Brain bank Criteria
• Hoehn & Yahr Stadium I to IV
• Age 40 to 99 years
• written and signed informed consent
• self-reported dexterous difficulties

Exclusion Criteria:

• MoCA <21/30
• psychiatric disease
• participation on other interventional trials
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
• severe visual impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Virtual reality upper limb hand training; The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.	Other: virtual reality upper limb hand training; The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.
Other: Virtual reality control training; The PD patients randomized in the control group will receive virtual reality control training.	Other: virtual reality control training; The PD patients randomized in the control group will receive virtual reality control training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fine finger movements	Coin rotation task (CRT): The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD. The seconds for 20 halfturns will be measured.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hand dexterity	Nine Hole Peg test (9-HPT): The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD. seconds will be measured.	4 weeks
grip strenght	The handheld JAMAR dynamometer measures the grip strength. kg will be measured.	4 weeks
motor function	MDS-Sponsored Revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS III): It evaluates motor aspects of Parkinson's disease	4 weeks
self-reported dexterity related problems in daily living	Dexterity Questionnaire 24 (DextQ-24): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD. score range 24-96, higher scores mean more dexterity problems.	4 weeks
self-reported problems in quality of life	Parkinson's Disease Questionnaire (PDQ-39): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating QOL in PD. range 0-156, higher values mean more problems.	4 weeks

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Principal Investigator: Tim Vanbellingen, Prof, Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Movement Disorders; Parkinson Disease; Central Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; dexterity; virtual reality training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2022-01545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No