Parkinson DiseaseNCT03406728
Virtual Reality Can be Used to Improve Balance Reducing Dynamic Falls in Those With Parkinson's Disease
A study testing PDSAFEX and VIRTUAL REALITY in people with Parkinson Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
Trial summary
This study aims to explore the use of full immersion virtual reality technology on improving balance in those with Parkinson's Disease. Patients will be immersed in a virtual environment and be tasked with completed games and activities, which mirror activities of daily living. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PDSAFEX and VIRTUAL REALITY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2018to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed with diagnosis with Parkinson's Disease by a registered movement disorders specialist
- Either gender
- Currently taking dopaminergic medication
- Able to walk 15m, unassisted
- Able to stand for 2 minutes unassisted
- Able to understand English Instructions
- Normal or corrected visions
Who cannot join
- Any other neurological disorder
- MoCa Score less than 18
- Commonly experiences vertigo, dizziness or motion sickness
- Seizures or dizziness due to light
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Waterloo, Ontario, N2L 3C5
About this study
This study aims to explore the use of full immersion virtual reality technology on improving balance in those with Parkinson's Disease. Patients will be immersed in a virtual environment and be tasked with completed games and activities, which mirror activities of daily living. It is hypothesized that this immersion in the virtual reality environment will improve their sensory pathways which are used to improve balance, decreasing falls.
Read the detailed description
I will utilize a randomized independent measures single blind study. Meaning participants will be randomly assigned to three different groups. The randomization process will be completed by the primary investigator, using a computer randomization software. Essentially, participants will all be given numbers which will be entered into the software, which then randomly assigns them to one of the three groups. The groups are: the virtual reality intervention group, the PDSAFEX group and the control group. Dr. Almeida, the tester of UPDRS scores, will be unaware of which groups each participant is in - only I will be aware. I aim to recruit about thirty-six individuals (12 per group). The study will last twelve weeks. It will include: pre-testing and post-testing with a one month follow up. However, due to time constrains the post testing may be completed after 8 weeks so I can begin to analyze data and have a write up for my classmates and professors. There will still be the scheduled post testing and follow up after the fact at the specified original times (12 weeks and 1 month follow up). Participants will come into the MDRC three times per week. Depending on their group they will complete the PDSAFEX training or VR training intervention. PDSAFEX is a scripted intervention run by trained volunteers, it progresses in difficulty week by week. The VR technology group will complete a protocol that is associated with the software system of the device. They will be asked to complete exercises and/games aimed specifically at improving balance. For example, a game where they must dodge incoming objects while maintain good balance. Virtual reality, is also able to be increased in difficulty through changing the environment and/or stimuli characteristics/speed.
The virtual reality group will be exposed to the virtual reality simulation software for about 1 hour and 15 minutes including set up. They will complete a set of activities, games and exercises that are centered around improving balance. The activities and games are included in the software. The environment and difficulty of the protocol can be altered to make it more/less difficult depending on the participant's ability and/progression throughout the study.
The PDSAFEX intervention was created to improve an individual's sensory integration with a focus on improving balance. It consists of a 12-week protocol administered by trained volunteers. Each session lasts about 1 hour. Each week of the PDSAFEX protocol increases in either difficulty/volume to allow consistent improvements. Furthermore, some of the conditions/exercises are attempted under dim lights or with eyes closed to further stress the focus on limiting visual domains. Focusing on proprioception.
The control group will come in to the MDRC facility, to complete testing (pre, post and follow up). The participants in this group will be asked to continue their lifestyles without any drastic changes for the duration of the study.
- Conditions
- Parkinson Disease
- Being tested
- PDSAFEX, CONTROL, VIRTUAL REALITY
- Keywords
- Parkinson's Disease, Virtual Reality, Training, Balance, Falls, PDSAFEX
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDSAFEXOther
PDSAFEX is a week by week, progressive, exercise protocol that is followed. It lasts 12 weeks.
CONTROLOther
Participants will be asked to maintain their day to day life as consistently as possible for the 12 week duration of the study.
VIRTUAL REALITYDevice
WorldViz Oculus Rift Move package (headset and software).
| Study group | Role | What they receive |
|---|---|---|
| PDSAFEX GROUP | Active comparator | Parkinson's Disease Sensory Attention Focused Exercise (PDSAFEX) is an exercise intervention developed in light of research which focuses on utilizing sensory integration and proprioception to improve balance. This intervention will be administered to one group of my participants. The protocol will be followed and led by trained volunteers. Receives: Other: PDSAFEX |
| CONTROL GROUP | Active comparator | The control group in this study will be asked to maintain their daily lifestyle as closely as possible for the 12-week duration of the study. Receives: Other: CONTROL |
| VIRTUAL REALITY GROUP | Experimental | Virtual reality intervention will be assigned to this group. They will complete activities aimed at improving their dynamic balance. These activities are specifically developed based on previous literature and geared towards mirroring day to day activities/scenarios that individuals with PD may come into contact with. Receives: Device: VIRTUAL REALITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Assesses the burden and extent of Parkinson's Disease over the course of the disease.
Measured: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Sensory Organization Tests (SOT- 6)
The sensory organization test is a set of six tests which measures an individuals balance under six different conditions. More specifically, it assess quantitative data about visual, proprioceptive and vestibular cues in order to maintain postural stability in stanceIt is completed using the Biodex machine.
Measured: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in the number of Falls utilizing a Fall Calendar
Subjective response that identifies the number of falls an individual participant has experienced. Participants will be supplied with a falls calendar which they will fill out and bring back in to the primary researcher.
Measured: The calendar will be completed daily but the results handed in at the end of each month for the duration of the study. The study will last three months, as such there should be three completed calendars.
Secondary outcomes (5)
Change in Timed up and Go (TUG)
The timed up and go test is an objective measure of balance, walking ability and fall risk in older adults.
Measured: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Activities Specific Balance Confidence scale (ABC scale)
A subjective measure of confidence in completing certain activities of daily living or ambulatory actions without falling or experiencing unsteadiness.
Measured: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Gait Analysis
Measurement of an individuals step length, stride length, step variability and center of pressure. The results are all computed through the software; it provides you with all of the results after each trial of the test.
Measured: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Falls Efficacy Scale (FES)
Assesses the perception of balance, stability and the fear of falling during activities of daily living.
Measured: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Parkinson's Disease Questionnaire (PDQ-39)
A self report questionnaire which assesses an individual's Parkinson's specific health quality over quality over the last month, their experience and difficulties in completing activities in the eight quality of life dimensions and the impact of Parkinson's on specific areas of wellbeing and functioning.
Measured: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start21 Jan 2018 (estimated)
- Primary completion30 Apr 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quincy J Almeida, PhD, Study director, SunLife Movement Disorders Research and Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406728
- Sponsor's protocol ID
- MDRC
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Can be Used to Improve Balance Reducing Dynamic Falls in Those With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03406728
- Acronym / sponsor ID
- MDRC
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Virtual Reality, Training, Balance, Falls, PDSAFEX
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- 21 Jan 2018 (estimated)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the use of full immersion virtual reality technology on improving balance in those with Parkinson's Disease. Patients will be immersed in a virtual environment and be tasked with completed games and activities, which mirror activities of daily living. It is hypothesized that this immersion in the virtual reality environment will improve their sensory pathways which are used to improve balance, decreasing falls.
Detailed description
I will utilize a randomized independent measures single blind study. Meaning participants will be randomly assigned to three different groups. The randomization process will be completed by the primary investigator, using a computer randomization software. Essentially, participants will all be given numbers which will be entered into the software, which then randomly assigns them to one of the three groups. The groups are: the virtual reality intervention group, the PDSAFEX group and the control group. Dr. Almeida, the tester of UPDRS scores, will be unaware of which groups each participant is in - only I will be aware. I aim to recruit about thirty-six individuals (12 per group). The study will last twelve weeks. It will include: pre-testing and post-testing with a one month follow up. However, due to time constrains the post testing may be completed after 8 weeks so I can begin to analyze data and have a write up for my classmates and professors. There will still be the scheduled post testing and follow up after the fact at the specified original times (12 weeks and 1 month follow up). Participants will come into the MDRC three times per week. Depending on their group they will complete the PDSAFEX training or VR training intervention. PDSAFEX is a scripted intervention run by trained volunteers, it progresses in difficulty week by week. The VR technology group will complete a protocol that is associated with the software system of the device. They will be asked to complete exercises and/games aimed specifically at improving balance. For example, a game where they must dodge incoming objects while maintain good balance. Virtual reality, is also able to be increased in difficulty through changing the environment and/or stimuli characteristics/speed.
The virtual reality group will be exposed to the virtual reality simulation software for about 1 hour and 15 minutes including set up. They will complete a set of activities, games and exercises that are centered around improving balance. The activities and games are included in the software. The environment and difficulty of the protocol can be altered to make it more/less difficult depending on the participant's ability and/progression throughout the study.
The PDSAFEX intervention was created to improve an individual's sensory integration with a focus on improving balance. It consists of a 12-week protocol administered by trained volunteers. Each session lasts about 1 hour. Each week of the PDSAFEX protocol increases in either difficulty/volume to allow consistent improvements. Furthermore, some of the conditions/exercises are attempted under dim lights or with eyes closed to further stress the focus on limiting visual domains. Focusing on proprioception.
The control group will come in to the MDRC facility, to complete testing (pre, post and follow up). The participants in this group will be asked to continue their lifestyles without any drastic changes for the duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDSAFEX GROUP | Active comparator | Other: PDSAFEXParkinson's Disease Sensory Attention Focused Exercise (PDSAFEX) is an exercise intervention developed in light of research which focuses on utilizing sensory integration and proprioception to improve balance. This intervention will be administered to one group of my participants. The protocol will be followed and led by trained volunteers. |
| CONTROL GROUP | Active comparator | Other: CONTROLThe control group in this study will be asked to maintain their daily lifestyle as closely as possible for the 12-week duration of the study. |
| VIRTUAL REALITY GROUP | Experimental | Device: VIRTUAL REALITYVirtual reality intervention will be assigned to this group. They will complete activities aimed at improving their dynamic balance. These activities are specifically developed based on previous literature and geared towards mirroring day to day activities/scenarios that individuals with PD may come into contact with. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed with diagnosis with Parkinson's Disease by a registered movement disorders specialist
- Either gender
- Currently taking dopaminergic medication
- Able to walk 15m, unassisted
- Able to stand for 2 minutes unassisted
Key exclusion criteria (4 listed)
- Any other neurological disorder
- MoCa Score less than 18
- Commonly experiences vertigo, dizziness or motion sickness
- Seizures or dizziness due to light
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDSAFEXPDSAFEX is a week by week, progressive, exercise protocol that is followed. It lasts 12 weeks. | Other | PDSAFEX GROUP |
| CONTROLParticipants will be asked to maintain their day to day life as consistently as possible for the 12 week duration of the study. | Other | CONTROL GROUP |
| VIRTUAL REALITYWorldViz Oculus Rift Move package (headset and software). | Device | VIRTUAL REALITY GROUP |
Primary outcome
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Assesses the burden and extent of Parkinson's Disease over the course of the disease.
Change in Sensory Organization Tests (SOT- 6)
Time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
The sensory organization test is a set of six tests which measures an individuals balance under six different conditions. More specifically, it assess quantitative data about visual, proprioceptive and vestibular cues in order to maintain postural stability in stanceIt is completed using the Biodex machine.
Change in the number of Falls utilizing a Fall Calendar
Time frame: The calendar will be completed daily but the results handed in at the end of each month for the duration of the study. The study will last three months, as such there should be three completed calendars.
Subjective response that identifies the number of falls an individual participant has experienced. Participants will be supplied with a falls calendar which they will fill out and bring back in to the primary researcher.
5 secondary outcomes
Change in Timed up and Go (TUG)
Time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Activities Specific Balance Confidence scale (ABC scale)
Time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Gait Analysis
Time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Falls Efficacy Scale (FES)
Time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Change in Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quincy J Almeida, PhD study director
SunLife Movement Disorders Research and Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDSAFEX and VIRTUAL REALITY in people with Parkinson Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke A. Simpson (2892219050, simp0290@mylaurier.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406728, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.