NCT03727529

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)). On the other hand, treadmill walking has shown long-term effectiveness on PD patients' gait and quality of life. The purpose of this single blinded randomized controlled trial is to study the effect of a combination of immersive virtual reality and treadmill walking on LRA.

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
46

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

October 29, 2018

Last Update Submit

March 18, 2019

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Keywords

Parkinson's DiseaseVirtual realityLong range autocorrelations

Outcome Measures

Primary Outcomes (2)

  • Long-Range Autocorrelations: H exponent

    First, stride duration will be assessed using accelerometers. After this, temporal varibility of stride duration will be assessed using the Rescaled Range Analysis (H exponent) to get the Long Range Autocorrelations.

    Change from baseline in H exponent at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

  • Long-Range Autocorrelations: Alpha exponent

    First, stride duration will be assessed using accelerometers. After this, temporal varibility of stride duration will be assessed using the Power Spectral Density (Alpha exponent) to get the Long Range Autocorrelations.

    Change from baseline in Alpha exponent at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

Secondary Outcomes (10)

  • Mean gait speed

    Change from baseline in mean gait speed at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

  • Step length

    Change from baseline in step length at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

  • Gait cadence

    Change from baseline in gait cadence at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

  • Coefficient of variation of stride duration

    Change from baseline in coefficient of variation at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

  • Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS)

    Change from baseline in MDS-UPDRS at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

  • +5 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: Treadmill + VR

Control group

ACTIVE COMPARATOR
Other: Treadmill

Interventions

Treadmill + VROTHER

Patients will walk on the tredmill with the virtual reality headset. Patients will walk in a straight line in a coherent, immersive and simple virtual environment. Before the first session, a 15-minute session will focus on patient familiarization with iVR

Intervention group
TreadmillOTHER

Patients will walk on the treadmill without iVR. Patients will also receive a short familiarization to the treadmill before strating the experimentation.

Control group

Eligibility Criteria

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

You may qualify if:

  • Parkinson's Disease diagnosis made according to UK Brain Bank criteria
  • Hoehn and Yahr score of 1 to 3 (physically independent, able to walk unassisted)
  • In ON phase during assessments and treatment sessions

You may not qualify if:

  • Other pathologies that increase risk of falling
  • Other pathologies that increase risk of nausea and vertigo
  • Contraindication to physical exercising (ACSM criteria)
  • Freezing of gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Central Study Contacts

Alexis Lheureux, MD

CONTACT

27645375alexis.lheureux@uclouvain.be

Thierry Lejeune, MD, PhD

CONTACT

27641648thierry.lejeune@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 1, 2018

Study Start

January 30, 2019

Primary Completion

September 1, 2019

Study Completion

January 1, 2020

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

BE(1)