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Immersive Virtual Reality to Improve Gait in Parkinson's Disease (NMSK-LH02)

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ClinicalTrials.gov Identifier: NCT03727529
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Gait Disorders, Neurologic Other: Treadmill + VR Other: Treadmill Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Immersive Virtual Reality on Treadmill to Improve Gait in Parkinson's Disease: a Single Blinded, Randomized Controlled Trial
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group Other: Treadmill + VR
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

Active Comparator: Control group Other: Treadmill
Patients will walk on the treadmill without iVR. Patients will also receive a short familiarization to the treadmill before strating the experimentation.




Primary Outcome Measures :
  1. Long-Range Autocorrelations: H exponent [ Time Frame: Change from baseline in H exponent at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    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.

  2. Long-Range Autocorrelations: Alpha exponent [ Time Frame: Change from baseline in Alpha exponent at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    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.


Secondary Outcome Measures :
  1. Mean gait speed [ Time Frame: Change from baseline in mean gait speed at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    Total walking distance (m)/ Acquisition duration (s)

  2. Step length [ Time Frame: Change from baseline in step length at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    Gait speed (m/s)*60/Gait cadence (steps/min)

  3. Gait cadence [ Time Frame: Change from baseline in gait cadence at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    Total number of steps (#)/Acquisition duration (min)

  4. Coefficient of variation of stride duration [ Time Frame: Change from baseline in coefficient of variation at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    [SD/mean stride duration] * 100

  5. Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) [ Time Frame: Change from baseline in MDS-UPDRS at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    A global scale about Parkinson's Disease symptoms ranging from 0-272. MDS-UPDRS part III is the motor subscale ranging from 0-132. Higher values represent a worse outcome.

  6. 2 minutes walk distance [ Time Frame: Change from baseline in 2 minutes walk distance at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
  7. Balance Evaluation Systems Test (BESTest) [ Time Frame: Change from baseline in BESTest at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
  8. Simplified version of the Activities-specific Balance Confidence Scale (ABC-Scale) [ Time Frame: Change from baseline in ABC-Scale at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    It is a questionnaire to assess the degree of confidence of the person in his balance associated with gestures of daily life. The score is a percentage obtained as follows: (total score obtained from the 15 items / 45) x 100. Minimum score is 0% and maximum score is 100%. Each item scores from 0 to 3. Higher values represent a better outcome.

  9. Fall diary [ Time Frame: Change from baseline in number of falls at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    Number of falls that occur during the follow up, assessed by the patient

  10. The 39-items Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Change from baseline in PDQ-39 at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks ]
    This is a 39 items quality of life questionnaire specific to Parkinson's disease. Each item scores from 0 to 4. The total score is from 0 to 156. Higher values represent a worse outcome.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Optimal drug treatment for at least 4 weeks at the time of inclusion
  • In ON phase during assessments and treatment sessions

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727529


Contacts
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Contact: Alexis Lheureux, MD 27645375 ext +32 alexis.lheureux@uclouvain.be
Contact: Thierry Lejeune, MD, PhD 27641648 ext +32 thierry.lejeune@uclouvain.be

Locations
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Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Alexis Lheureux         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03727529     History of Changes
Other Study ID Numbers: 2018/26MAR/132
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Parkinson's Disease
Virtual reality
Long range autocorrelations
Additional relevant MeSH terms:
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Parkinson Disease
Gait Disorders, Neurologic
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms