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Completed

NCT Number: NCT03515746

3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

About this study

The participants will practise grab and grasp in virtual environment (VE), either on a laptop computer or using 3D goggles. They will sit in a comfortable chair, with a small camera tracking the hand and finger movements of their affected (dominant, in case of both hands affected) hand. The participant will grab any of the virtual cubes lying around the VE and put it in the treasure box. When the cube falls into the treasure box it disappears and the participant scores, one by one until the 10th cube or 120s of time elapse. The cubes will be randomly spread in the VE and will all have the same virtual size, weight and bouncing factor, but different colour. If the participant is left-handed, the treasure box will be mirrored to the right side. If the cube is pushed into the floor, it disappears without a score and is lost. Each participant will take 10 consecutive training sessions in 2 weeks, each session lasting for 30min. Within a session, the participant will take 5 trials, with breaks of 1-2 min between them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exergaming in virtual environment

Device

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

Primary outcomes

  1. UDPRS III Motor

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

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

  2. BBT

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

    Box & Blocks Test - difference score

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Collaborators

  • European Regional Development Fund
  • Slovenian Research Agency

Registry information

Acronym: 10Cubes

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 4, 2018
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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