NCT04019158

Brief Summary

Parkinson's Disease (PD) patients suffer from gait impairments responsible for falls and bad quality of life: reduced speed and stride length, randomness in stride duration variability (reduced Long-Range Autocorrelations (LRA)). This pilot study will compare the spatio-temporal walking parameters and LRA of PD patients tested under three conditions: walking over ground, walking on a treadmill and walking on a treadmill in virtual reality. The aim is to determine the effect on gait of an optical flow recreated in virtual reality, by means of a virtual reality headset, on a treadmill.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 10, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 9, 2019

Last Update Submit

May 4, 2020

Conditions

Parkinson DiseaseVirtual RealityGait Disorders, NeurologicLong Range Autocorrelations

Keywords

Parkinson's DiseaseVirtual realityGaitVariabilityFractal

Outcome Measures

Primary Outcomes (1)

  • Long-Range Autocorrelations

    Long-Range Autocorrelations

    Change from baseline in long-range autocorrelations during each intervention condition (3 x 10 min walking)

Secondary Outcomes (5)

  • Mean gait speed

    Change from baseline in mean gait speed during each intervention condition (3 x 10 min walking)

  • Step length

    Change from baseline in step length during each intervention condition (3 x 10 min walking)

  • Gait cadence

    Change from baseline in gait cadence during each intervention condition (3 x 10 min walking)

  • Coefficient of variation of stride duration

    Change from baseline in coefficient of variation during each intervention condition (3 x 10 min walking)

  • Simulator Sickness Questionnaire (SSQ)

    Change from baseline in SSQ after the VRW condition

Study Arms (1)

Parkinson's Disease patients

EXPERIMENTAL

Parkinson's Disease patients will walk in three conditions for +- 15 minutes per condition: walking over ground, walking on a treadmill, walking on a treadmill in virtual reality

Device: Virtual reality headset

Interventions

Virtual reality headsetDEVICE

All participants will walk in the three conditions described earlier in this form

Parkinson's Disease patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PD patients:
  • idiopathic PD diagnosis made by an experienced neurologist according to United Kingdom Brain Bank criteria
  • mild to moderate motor disorders according to modified Hoehn \& Yahr scale (stages I-III)
  • ability to walk for a minimum of 512 gait cycles (±15 minutes) in a row without walking aids
  • no other pathology interacting with gait or provoking dizziness
  • no uncorrected vision disorders
  • a minimum of 24/30 on the Mini-Mental State Examination (MMSE)

You may not qualify if:

  • PD Patients:
  • other neurological or orthopedic pathologies that could interact with their motor capacities and gait performance
  • pathology that could provoke vertigo or nausea
  • uncorrected vision disorders
  • contraindications to physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thierry Lejeune, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

July 15, 2019

Study Start

April 10, 2019

Primary Completion

September 19, 2019

Study Completion

September 19, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)