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

Sponsor

Luzerner Kantonsspital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05965661

Collaborator

(none)

Enrollment

Location

Arms

29.4

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: virtual reality upper limb hand training Other: virtual reality control training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized pilot studyRandomized pilot study

Masking:

Single (Outcomes Assessor)

Masking Description:

VR upper limb hand training or VR control training

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 19, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

fine finger movements [4 weeks]
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.

Secondary Outcome Measures

hand dexterity [4 weeks]
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.
grip strenght [4 weeks]
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
motor function [4 weeks]
MDS-Sponsored Revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS III): It evaluates motor aspects of Parkinson's disease
self-reported dexterity related problems in daily living [4 weeks]
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.
self-reported problems in quality of life [4 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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