Virtual Reality Can be Used to Improve Balance Reducing Dynamic Falls in Those With Parkinson's Disease

NCT ID: NCT03406728

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-21
• Study Completion Date: 2018-05-30

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PDSAFEX GROUP

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.

Group Type: ACTIVE_COMPARATOR

PDSAFEX

Intervention Type: OTHER

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

CONTROL GROUP

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.

Group Type: ACTIVE_COMPARATOR

CONTROL

Intervention Type: OTHER

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

VIRTUAL REALITY GROUP

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.

Group Type: EXPERIMENTAL

VIRTUAL REALITY

Intervention Type: DEVICE

WorldViz Oculus Rift Move package (headset and software).

Interventions

PDSAFEX

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

Intervention Type: OTHER

CONTROL

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

Intervention Type: OTHER

VIRTUAL REALITY

WorldViz Oculus Rift Move package (headset and software).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quincy J Almeida, PhD

Role: STUDY_DIRECTOR

SunLife Movement Disorders Research and Rehabilitation Center

Locations

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Waterloo, Ontario, Canada

Countries

Canada

Central Contacts

Luke A. Simpson

Role: CONTACT

simp0290@mylaurier.ca

2892219050

References

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.

Reference Type: DERIVED

PMID: 38588457 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36602886 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MDRC

Identifier Type: -

Identifier Source: org_study_id