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

January 27, 2020 updated by: Universidad San Jorge

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50015
        • Asociación de Parkinson de Aragón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4-weeks
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.
Baseline and 4-weeks
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).
Baseline and 4-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad San Jorge

Investigators

  • Principal Investigator: Pablo Herrero, PhD, Universidad San Jorge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI18/386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are currently no plan on sharing data from this study with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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