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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
virtual reality upper limb hand training
virtual reality control training
Sponsored by
Luzerner Kantonsspital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, virtual reality training, dexterity, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Luzerner KantonsspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Virtual reality upper limb hand training

Virtual reality control training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
grip strenght
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
motor function
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
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
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.

Full Information

First Posted
July 13, 2023
Last Updated
July 20, 2023
Sponsor
Luzerner Kantonsspital
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1. Study Identification

Unique Protocol Identification Number
NCT05965661
Brief Title
A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease
Official Title
A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease: a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luzerner Kantonsspital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, virtual reality training, dexterity, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized pilot study
Masking
Outcomes Assessor
Masking Description
VR upper limb hand training or VR control training
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality upper limb hand training
Arm Type
Other
Arm Description
The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.
Arm Title
Virtual reality control training
Arm Type
Other
Arm Description
The PD patients randomized in the control group will receive virtual reality control training.
Intervention Type
Other
Intervention Name(s)
virtual reality upper limb hand training
Intervention Description
The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.
Intervention Type
Other
Intervention Name(s)
virtual reality control training
Intervention Description
The PD patients randomized in the control group will receive virtual reality control training.
Primary Outcome Measure Information:
Title
fine finger movements
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
hand dexterity
Description
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.
Time Frame
4 weeks
Title
grip strenght
Description
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
Time Frame
4 weeks
Title
motor function
Description
MDS-Sponsored Revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS III): It evaluates motor aspects of Parkinson's disease
Time Frame
4 weeks
Title
self-reported dexterity related problems in daily living
Description
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.
Time Frame
4 weeks
Title
self-reported problems in quality of life
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cornelia Cox, MSc
Phone
041 205 56 80
Email
cornelia.cox@luks.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Pastore, PhD
Phone
041 205 72 20
Email
manuela.pastore@luks.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Vanbellingen, Prof
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luzerner Kantonsspital
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Pastore, PhD
Phone
0412057220
Email
manuela.pastore@luks.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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