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Completed

NCT Number: NCT05690308

Visual Perturbation Training to Reduce Fall Risk in People with Parkinson's Disease

Falls during walking are common in people with Parkinson's Disease (PD). Fall risk can be attributed in part to the loss of automaticity in walking and an increased reliance on sensory cues, such as the input from the balance organ. In this project the investigators want to assess the effectiveness of rehabilitation training aiming to improve this vestibular input. The effects of a visual perturbation training in a virtual reality environment will be compared to conventional treadmill training.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Ear Diseases Falling Gait Labyrinth Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinsonian Disorders Synucleinopathies Vestibular Diseases Vestibular Disorder

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent

Ghent, East-Flanders, 9000, Belgium

About this study

Fifty participants (50-65 years) with idiopathic PD (Hoehn & Yahr scale 2-3) will be randomly assigned to the intervention group receiving four weeks of VPT in a VR environment using the Gait Real-time Analysis Interactive Lab system (GRAIL) or a control group receiving four weeks of regular treadmill training. Primary outcome measures are spatio-temporal outcome parameters of gait and dynamic stability (gait speed, stride time/length, cadence, step-to-step variability, step width variability and trunk sway), and self-reported falls, and will be recorded at all testing phases (pre-test, after baseline, after intervention and after detraining). Secondary outcome measures will include assessments of central and peripheral vestibular function (Cervical and ocular Vestibular Evoked Myogenic Potentials) for correlation with the primary outcome measures. The secondary outcomes will be recorded at pre-testing and directly after the intervention phase.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic Parkinson's disease
  • Aged between 50-65 years
  • Bilateral symptoms
  • Able to walk unassisted for 20 minutes (Hoehn & Yahr stage II-III)
  • Stable medication dosage (if any)
  • No cognitive disablity

Exclusion criteria

  • Non-idiopathic Parkinson's disease
  • Strong variation in expressed symptoms
  • Inability to walk unassisted for 20 minutes
  • Underwent a medical procedure to treat Parkinson symptoms (e.g. duodopa pump, deep brain stimulator)
  • Cognitive disability (score < 21 on the Montreal Cognitive Assessment)
  • Illness other than Parkinson's disease (flu, Covid-19) or disabilities that may affect gait or equilibrium
  • Clogged ear(s)
  • Regular fainting episodes
  • Weight over 120 kg
  • Participation in other clinical studies

Treatment and study plan

Visual perturbation treadmill training

Other

12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill in a virtual reality environment (Gait Real-time Analysis Interactive Lab system, MOTEK) with projected visual perturbations.

Regular treadmill training

Other

12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill

Primary outcomes

  1. Change from baseline in gait speed after 6 weeks training

    Time frame: Week 1 to week 6 of training intervention

    Delta in average gait speed in m/s

  2. Change from baseline in cadence after 6 weeks training

    Time frame: Week 1 to week 6 of training intervention

    Delta in steps per minute

  3. Change from baseline in stride time after 6 weeks training

    Time frame: Week 1 to week 6 of training intervention

    Delta in average duration (+variability) of a single step in ms

  4. Change from baseline in step length after 6 weeks training

    Time frame: Week 1 to week 6 of training intervention

    Delta in average length (+variability) of a single step in cm

  5. Change from baseline in step width after 6 weeks training

    Time frame: Week 1 to week 6 of training intervention

    Delta in average width(+variability) of a single step in cm

  6. Change from baseline in trunk sway after 6 weeks training

    Time frame: Week 1 to week 6 of training intervention

    Delta in medio-lateral and anterior-posterior movement of the center of mass as determined using 3D motion capturing in cm

Secondary outcomes

  1. Assessments of central and peripheral vestibular function

    Time frame: Pre-test 1 at start of the study

    Cervical and ocular vestibular evoked myogenic potentials

  2. Assessments of central and peripheral vestibular function

    Time frame: Post-test within 1 week after conclusion of the training intervention

    Cervical and ocular vestibular evoked myogenic potentials

  3. Self-reported falls

    Time frame: Monthly up to six months after last training

    Falls recorded in fall diary

Other outcomes

  1. Assessment of fear of falling

    Time frame: Pre-test 2 at start of the study

    Fear of falling recorded using the Iconographical Falls Efficacy Scale

  2. Assessment of fear of falling

    Time frame: Post-test within 1 week after conclusion of the training intervention

    Fear of falling recorded using the Iconographical Falls Efficacy Scale

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

A Novel Training Method to Reduce Fall Risk in People with Parkinson's Disease: the Role of the Balance Organ

Acronym: Vesti-PD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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