NCT03515746

Brief Summary

A pilot study with the "10cubes" for small and precise movements and training in the virtual environment will be carried out. We will recruit at least 20 persons with Parkinson's disease to participate in the study. Such activities can increase participation, slow down the progress of the disease and contribute to the functional improvements of the hand that lead to the increased quality of life. The movement of the hand will be assessed with a small 3D camera, also suitable for the estimation of kinematic parameters. Participants will be randomized into 2 groups; one group using an LCD screen and the other using 3D goggles (Oculus Rift CV1) enabling them to carry out the task in virtual environment. Both groups will take 10 training sessions within 2 weeks. Their task will be collecting 10 virtual cubes one-by-one and putting them in the virtual treasure box. Clinical tests (Box and Blocks Test and motor part of the UPDRS) will be carried out in the clinical settings prior and after the training sessions. We hypothesise that the different feedback equipment may provide different results.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

April 23, 2018

Last Update Submit

December 17, 2018

Conditions

Keywords

exergamingphysiotherapyupper extremitiestelerehabilitation

Outcome Measures

Primary Outcomes (2)

  • UDPRS III Motor

    Unified Parkinson's Disease Rating Scale Motor Function Part - difference score

    DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session

  • BBT

    Box \& Blocks Test - difference score

    DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session

Study Arms (2)

Exergaming2D

ACTIVE COMPARATOR

The participants will practise grab and grasp through exergaming in virtual environment (VE) on a laptop computer. During the task, they will sit in a comfortable chair in front of the screen.

Device: Exergaming in virtual environment

Exergaming3D

ACTIVE COMPARATOR

The participants will practise grab and grasp through exergaming in virtual environment (VE) in 3D VE using Oculus Rift CV1 3D goggles. During the task, they will sit in a comfortable chair with head-mounted 3D display.

Device: Exergaming in virtual environment

Interventions

The "10 cubes" task will be performed in virtual environment - either in 2D on a laptop computer or in 3D using 3D goggles

Exergaming2DExergaming3D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease diagnosis
  • minor problems with daily activities and upper extremities
  • Hoehn and Yahr Scale level 2-3

You may not qualify if:

  • insufficient cognitive and motor abilities to carry out the exergaming task

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • Cikajlo I, Peterlin Potisk K. Advantages of using 3D virtual reality based training in persons with Parkinson's disease: a parallel study. J Neuroeng Rehabil. 2019 Oct 17;16(1):119. doi: 10.1186/s12984-019-0601-1.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Imre Cikajlo, PhD

    University Rehabilitation Institute, Republic of Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 4, 2018

Study Start

May 11, 2018

Primary Completion

December 16, 2018

Study Completion

December 16, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations