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Completed

NCT Number: NCT04117737

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Mobility Limitation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asociación de Parkinson de Aragón

Zaragoza, 50015, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Virtual reality combined with anti-gravity treadmill

Other

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Registry information

Official study title

Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 7, 2019
Registry last updated
Jan 28, 2020

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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