Parkinson Disease Clinical Trial
Official title:
Virtual Reality Can be Used to Improve Balance Reducing Dynamic Falls in Those With Parkinson's Disease
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.
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.
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