NCT03406728

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 8, 2018

Last Update Submit

January 15, 2018

Conditions

Parkinson Disease

Keywords

Parkinson's DiseaseVirtual RealityTrainingBalanceFallsPDSAFEX

Outcome Measures

Primary Outcomes (3)

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS)

    Assesses the burden and extent of Parkinson's Disease over the course of the disease.

    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.

    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.

    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)

    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)

    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

    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)

    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)

    Pre test (a week prior), post test after 8 weeks and follow up with a washout period one month after completion of study.

Study Arms (3)

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.

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.

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.

Device: VIRTUAL REALITY

Interventions

PDSAFEXOTHER

PDSAFEX is a week by week, progressive, exercise protocol that is followed. It lasts 12 weeks.

PDSAFEX GROUP
CONTROLOTHER

Participants will be asked to maintain their day to day life as consistently as possible for the 12 week duration of the study.

CONTROL GROUP
VIRTUAL REALITYDEVICE

WorldViz Oculus Rift Move package (headset and software).

VIRTUAL REALITY GROUP

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Waterloo, Ontario, N2L 3C5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 38588457DERIVED

  • 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Quincy J Almeida, PhD

    SunLife Movement Disorders Research and Rehabilitation Center

    STUDY DIRECTOR

Central Study Contacts

Luke A. Simpson

CONTACT

2892219050simp0290@mylaurier.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 23, 2018

Study Start

January 21, 2018

Primary Completion

April 30, 2018

Study Completion

May 30, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

CA(1)