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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965661
• Other study ID #: 2022-01545
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Luzerner Kantonsspital
• Contact: Cornelia Cox, MSc
• Phone: 041 205 56 80
• Email: cornelia.cox[@]luks.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• virtual reality upper limb hand training
The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.
• virtual reality control training
The PD patients randomized in the control group will receive virtual reality control training.

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	grip strenght	The handheld JAMAR dynamometer measures the grip strength. kg will be measured.	4 weeks
Secondary	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
Secondary	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
Secondary	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