Clinical trial NCT03406728: Virtual Reality Can be Used to Improve Balance Reducing Dynamic Falls in Those With Parkinson's Disease
Official title: Virtual Reality Can be Used to Improve Balance Reducing Dynamic Falls in Those With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Virtual Reality
Training
Balance
Falls
PDSAFEX
Lead sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Any other neurological disorder
* MoCa Score less than 18
* Commonly experiences vertigo, dizziness or motion sickness
* Seizures or dizziness due to light

Primary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
measure: Change in Sensory Organization Tests (SOT- 6)
timeFrame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
measure: Change in the number of Falls utilizing a Fall Calendar
timeFrame: 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:
measure: Change in Timed up and Go (TUG)
timeFrame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
measure: Change in Activities Specific Balance Confidence scale (ABC scale)
timeFrame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
measure: Change in Gait Analysis
timeFrame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
measure: Change in Falls Efficacy Scale (FES)
timeFrame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
measure: Change in Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
state: Ontario
Study officials:
affiliation: SunLife Movement Disorders Research and Rehabilitation Center
name: Quincy J Almeida, PhD
role: STUDY_DIRECTOR
References: