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Trial registered on ANZCTR


Registration number
ACTRN12619001754134
Ethics application status
Approved
Date submitted
8/11/2019
Date registered
10/12/2019
Date last updated
12/11/2021
Date data sharing statement initially provided
10/12/2019
Date results information initially provided
12/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual reality balance-based training in patients with Parkinson's disease
Scientific title
Objective assessment of the efficacy of Virtual reality balance-based training using the Kinect sensor and force platform in patients with Parkinson's disease
Secondary ID [1] 299137 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 314203 0
Condition category
Condition code
Neurological 312562 312562 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 312563 312563 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main aim of the study is to assess in objective way the efficacy of custom-made virtual balance clinic system dedicated for patients with Parkinson's disease. Patients diagnosed with Parkinoson's disease (stage I-III) will be allocated to one of two experimental groups:
Group A: 12 training sessions of balance-based VR training
Group B: conventional balance training

Group A - participants will receive a 4-week balance-based VR intervention. The exercises will be administered for a total of 12 training sessions (3 training sessions per week).
Duration of each session: approximately 30 minutes

The VR balance training system will comprise two integrated devices, a custom-made force platform and a 3D measurement system based on time-of-flight cameras (Kinect sensor). Both devices will be used to control and verify movement execution.
Seven games will be used for training balance. Through avatar technology, images will be projected on the 65-inch screen which will be situated 2m away in front of the participant.
The participants will be introduced inside the video game as an avatar character which provided instantaneous visual feedback about patient’s movement execution. In each training session participants will practice the static posture maintaining, dynamic weight shifting, single leg standing, leaning in different directions, trunk rotation, steps making. Games will be adapted to the subject’s individual capabilities by changing several parameters in each game (i.e. movement velocity, frequency, range of weight distribution etc.) The physiotherapist always will attend the sessions and supervise for safety. Patients will always practice in "On" state. After inclusion in the study, patients will be asked to refrain from any other balance training.

The following measurements will be performed to objectively assess therapy effects:
I. Functional balance will be assessed using Limits of stability (LOS) test in forward direction, Functional Balance Test and Timed Up and Go test (TUG):
a) The LOS test will be repeated 3 times. Each trial will be divided into three phases: 1st phase - quiet standing (10s), 2nd phase - transition to maximum leaning position, 3rd phase - maintenance of the maximal forward-lean. In this task participants will be asked to stand quietly during the first 10s of the trial, then, after signal tone, to lean in the forward direction as quickly as possible without moving the feet and to maintain this position up to the end of the trial.
b) In the Functional Balance Test, the participants by leaning the body will rapidly shift the center of foot pressure to areas indicated on the screen without moving the feet. The COP point will be drawn in real time on the screen of the monitor, that will be placed in front of the participant. During the test, two areas with specific width and distance between them will appear alternately. The Functional Balance Test trial will be repeated 3 times.
c) Timed up and Go test will be repeated twice.
II. Static Stabilography (quiet standing test) will be carried out using custom-made force platform with integrated sensors to register center of foot pressure (COP) displacement.
Subjects will stand barefoot as still as possible on the force platform, maintaining their arms by their side while keeping their head straight. A total of 6 trials will performed: 3 trials with eyes open with gaze fixated at a reference point located 2 m away in front of the platform, and 3 trials with eyes closed.
III. Subjective assessment will be carried out with Berg Balance Scale.

All objective outcomes (postural stability and functional balance tests) and subjective assessment will be measured on 4 occasions: prior to intervention (baseline values), after 1, 6 training sessions and after the completion of the 4-week program.
Intervention code [1] 315803 0
Rehabilitation
Comparator / control treatment
group B - participants will receive a conventional balance rehabilitation, 12 training sessions (3 training sessions per week). One session supervised by physiotherapist (approximately 1 hour 15 minutes), two sessions at home (approximately 30 minutes). Each of the participant will receive exercise instructions (part 4 in brochure) and brochures dedicated for PD patients (http://parkinsonfundacja.pl/datastore/download/broszura_cwiczenia_srodek_do_inter.pdf)

Exercises will be divided into three different parts: few minutes of the warm-up exercises; main part where participants will perform static and dynamic balance exercises with reaching, leaning, weight shifting, forward, backward, and side stepping movements, The sessions will end with a few minutes of cooling down.
Control group
Active

Outcomes
Primary outcome [1] 321677 0
Measurement parameters of limits of stability test (LOS):
1) mean COP position relative to the lateral malleolus in the 1st phase (meanCOP1)
2) mean COP position relative to the lateral malleolus in the 3rd phase (meanCOP3 - range of forward lean)
3) leaning rate (LR - defined as linear regression coefficient of the 2nd phase),

Measurements will be done on a custom-made force platform which is part of the VR system, The data will be processed offline using the Matlab software
Timepoint [1] 321677 0
The outcome will be measured before intervention (baseline values), after 1, 6 training sessions and after the completion of the 4-week program.
Primary outcome [2] 321813 0
Measurement parameters of Functional Balance Test (FBT)
- average COP velocity (FvCOP)
- average time of target hit (FtCOP)
- movement optimization (FoCOP). Movement optimization is defined as the amount of movement in the intended direction plus the amount of extraneous movement. A FoCOP score of 0% indicates that the participant did not deviate from a straight path during the test.

Measurements will be done on a custom-made force platform which is part of the VR system, The data will be processed offline using the Matlab software
Timepoint [2] 321813 0
The outcome will be measured before intervention (baseline values), after 1, 6 training sessions and after the completion of the 4-week program.
Secondary outcome [1] 376283 0
Therapy effect will also be evaluated by using Timed Up and Go test (TUG)
Timepoint [1] 376283 0
The outcome will be measured before intervention (baseline values), after 6 training sessions and after the completion of the 4-week program.
Secondary outcome [2] 376284 0
Measurement parameters of quiet standing test:
sway range and COP velocity with its directional subcomponents: anteroposterior (ap) and mediolateral (ml).
Timepoint [2] 376284 0
The outcome will be measured before intervention (baseline values), after 1, 6 training sessions and after the completion of the 4-week program (primary endpoint).
Secondary outcome [3] 376286 0
Balance capabilities of performing functional tasks will be assessed using the Berg Balance Scale (BBS)
Timepoint [3] 376286 0
The outcome will be measured before intervention (baseline values), after 6 training sessions and after the completion of the 4-week program.

Eligibility
Key inclusion criteria
- diagnosed PD
- ability to perform the measurement and training without any aids
- no experience in virtual reality gaming.
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unstable medical condition
- histories of neurological, cardiovascular, or orthopedic diseases affecting postural stability
- diagnosed dementia
- vision deficits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/12/2019
Actual
18/12/2019
Date of last participant enrolment
Anticipated
2/11/2020
Actual
11/02/2020
Date of last data collection
Anticipated
30/11/2020
Actual
12/03/2020
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 22015 0
Poland
State/province [1] 22015 0
Silesia

Funding & Sponsors
Funding source category [1] 303676 0
Government body
Name [1] 303676 0
STRATEGMED3/ 306011/1/NCBR/2017
Country [1] 303676 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education
Address
Mikolowska 72a, 40-065 Katowice, Poland
Country
Poland
Secondary sponsor category [1] 303782 0
None
Name [1] 303782 0
Address [1] 303782 0
Country [1] 303782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304198 0
The Research Ethics Committee from Medical University of Warsaw
Ethics committee address [1] 304198 0
Zwirki i Wigury 61, 02-091 Warszawa
Ethics committee country [1] 304198 0
Poland
Date submitted for ethics approval [1] 304198 0
Approval date [1] 304198 0
18/02/2014
Ethics approval number [1] 304198 0
KB/28/2014

Summary
Brief summary
Parkinson's disease is a progressive condition. This neurodegenerative condition substantially affects patient functioning and quality of life. Reduced balance control is strongly associated with increased risk for falls what in consequence often lead to concurrent limiting of patients physical activity levels. These factors highlight a high need for the development and application of effective training methods. Main objective of this study is to determine and compare the efficacy of virtual reality (VR) balance-based therapy and conventional therapy for PD patients. Participants qualified for the study will be allocated to one of two experimental groups: Group A will receive VR training and group B conventional training. Posturographic measurements, functional balance test, forward body lean and subjective assessment will be taken prior to therapy after 1, 6 training sessions and after therapy completion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96122 0
Prof Grzegorz Juras
Address 96122 0
Department of Motor Behavior, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 96122 0
Poland
Phone 96122 0
+48 322075447
Fax 96122 0
Email 96122 0
[email protected]
Contact person for public queries
Name 96123 0
Anna Brachman
Address 96123 0
Department of Biomechanics, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 96123 0
Poland
Phone 96123 0
+48 322075160
Fax 96123 0
Email 96123 0
[email protected]
Contact person for scientific queries
Name 96124 0
Anna Brachman
Address 96124 0
Department of Biomechanics, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 96124 0
Poland
Phone 96124 0
+48 322075160
Fax 96124 0
Email 96124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5596Ethical approval    378266-(Uploaded-07-11-2019-23-09-51)-Study-related document.PDF



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Brachman, A.; Marszalek, W.; Kamieniarz, A.; Micha... [More Details]
Study results articleYes Brachman, A.; Marszalek, W.; Kamieniarz, A.; Micha... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBiomechanical measures of balance after balance-based exergaming training dedicated for patients with Parkinson's disease.2021https://dx.doi.org/10.1016/j.gaitpost.2021.04.036
N.B. These documents automatically identified may not have been verified by the study sponsor.