An interventional study of PDSAFEX and CONTROL in Parkinson Disease, sponsored by Sun Life Financial Movement Disorders Research and Rehabilitation Centre. Status unknown at 1 site in Canada. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Sun Life Financial Movement Disorders Research and Rehabilitation Centre · Not applicable, Interventional, and Treatment
Among 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre — none open to participants now, none under way, none of them phase 3. Parkinson Disease · Sun Life Financial Movement Disorders Research and Rehabilitation Centre.
Among the 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre, this one is the 8th largest by planned enrollment, is one of 3 that started in 2018, is one of 10 with no phase, and was the 7th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
Browse Parkinson Disease studies →None of the 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre is open now.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 55 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 3 started in 2018.
This study's planned enrollment of 36 is close to the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Median enrollment 57 across the 10 interventional studies. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Sun Life Financial Movement Disorders Research and Rehabilitation Centre is the lead sponsor of 10 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Parkinson Disease by Sun Life Financial Movement Disorders Research and Rehabilitation Centre, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: PDSAFEX
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.
Other: CONTROL
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.
Device: VIRTUAL REALITY
PDSAFEX is a week by week, progressive, exercise protocol that is followed. It lasts 12 weeks.
Participants will be asked to maintain their day to day life as consistently as possible for the 12 week duration of the study.
WorldViz Oculus Rift Move package (headset and software).
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Assesses the burden and extent of Parkinson's Disease over the course of the disease.
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 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.
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 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.
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.
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.
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)
A subjective measure of confidence in completing certain activities of daily living or ambulatory actions without falling or experiencing unsteadiness.
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
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.
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)
Assesses the perception of balance, stability and the fear of falling during activities of daily living.
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)
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.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Start is estimated for Jan 2018; primary completion for Apr 2018, 3 months later.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 3 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Sun Life Financial Movement Disorders Research and Rehabilitation Centre