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

NCT ID: NCT05965661

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-19

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease

Keywords

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Parkinson Disease virtual reality training dexterity Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
VR upper limb hand training or VR control training

Study Groups

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Virtual reality upper limb hand training

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

Group Type OTHER

virtual reality upper limb hand training

Intervention Type OTHER

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.

Group Type OTHER

virtual reality control training

Intervention Type OTHER

The PD patients randomized in the control group will receive virtual reality control training.

Interventions

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virtual reality upper limb hand training

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

Intervention Type OTHER

virtual reality control training

The PD patients randomized in the control group will receive virtual reality control training.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Vanbellingen, Prof

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

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Luzerner Kantonsspital

Lucerne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Cornelia Cox, MSc

Role: CONTACT

Phone: 041 205 56 80

Email: [email protected]

Manuela Pastore, PhD

Role: CONTACT

Phone: 041 205 72 20

Email: [email protected]

Facility Contacts

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Manuela Pastore, PhD

Role: primary

Other Identifiers

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2022-01545

Identifier Type: -

Identifier Source: org_study_id