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A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson

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ClinicalTrials.gov Identifier: NCT04117737
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad San Jorge

Brief Summary:
The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Gait Disorders, Neurologic Other: Virtual reality combined with anti-gravity treadmill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Outcomes assessor was blinded to outcomes values between sessions and to the adherence of participants to the intervention.
Primary Purpose: Treatment
Official Title: Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Single-arm
Other: Virtual reality combined with anti-gravity treadmill

The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.

The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.





Primary Outcome Measures :
  1. Changes in gait autonomy [ Time Frame: Baseline and 4-weeks ]
    Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface.


Secondary Outcome Measures :
  1. Changes in gait speed [ Time Frame: Baseline and 4-weeks ]
    Changes in gait speed will be measured by 10-Meter Walk Test (10MWT). The 10MWT consists of asking the subject to walk a 14m distance on flat area and measure the time spent from meter 2 to meter 12. Time will be measured by a digital chronometer. Gait speed will be calculated in meter per second.

  2. Changes in balance and gait ability [ Time Frame: Baseline and 4-weeks ]
    Changes in balance and gait ability will be measured by Tinetti scale. The Tinetti test is a simple, reproducible way of assessing the risk of falling in the elderly. This scale is composed of two value, static and dynamic: the test grants a maximum of 16 points for static part (sitting) and 12 point for dynamic (walking) part. Higher is the score, better is the performance.

  3. Changes in quality of life [ Time Frame: Baseline and 4-weeks ]
    Changes in quality of life will be measured by by 36-Item Short-Form Health Survey (SF-36). SF-36 assesses 8 physical and mental health domains: 1) Physical Functioning, 2) Social Functioning, 3) Role-Physical, 4) Bodily Pain, 5) Mental Health), 6) Role-Emotional, 7) Vitality, and 8) General Health. For each scale, item scores are coded, summed, and transformed, with final values expressed as a percentage, ranging from 0 (worst health) to 100 (best health).



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having Parkinson's disease diagnosed by a neurological doctor.
  • Having an alteration of the gait caused by the neurological disorder.
  • Being able to have an independent and voluntary walk of 10 meters as minimum.
  • Height more than 150 cm.

Exclusion Criteria:

  • Being blind.
  • Medical contraindications for walking.
  • Being amputee.
  • Alcohol or drugs abuse.
  • Other diseases that impedes the intervention.

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): NCT04117737


Contacts
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Contact: Pablo Bellosta-López, MSc +34650497072 pbellosta@usj.es

Locations
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Spain
Asociación de Parkinson de Aragón Recruiting
Zaragoza, Spain, 50015
Contact: Natalia Brandín    +34 620402088    fisio@parkinsonaragon.com   
Sponsors and Collaborators
Universidad San Jorge
Investigators
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Principal Investigator: Pablo Herrero, PhD Universidad San Jorge

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Responsible Party: Universidad San Jorge
ClinicalTrials.gov Identifier: NCT04117737     History of Changes
Other Study ID Numbers: PI18/386
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are currently no plan on sharing data from this study with other researchers.

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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 Universidad San Jorge:
Parkinson
Virtual reality
Anti-gravity treadmill
Rehabilitation
Gait disorders
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