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

Parkinson Disease Clinical Trial

— 10Cubes  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515746
• Other study ID #: URIS201801
• Status: Completed
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: December 16, 2018

Study information

• Verified date: December 2018
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 16, 2018
• Est. primary completion date: December 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia	European Regional Development Fund, Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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