Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease

Feasibility and Effectiveness of Virtual Reality and the Use of Body Weight Support Treadmill Training in Parkinson's Disease: an Explorative Study

The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Virtual Reality; Behavioral: Conventional Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofia Straudi, MD; Phone Number: +390532238720; Email: s.straudi@ospfe.it

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Recruiting
    • Ferrara University Hospital
    • Contact: Sofia Straudi, MD, PhD; Phone Number: 0532238720; Email: s.straudi@ospfe.it
    • Principal Investigator: Sofia Straudi, MD, PhD
    • Sub-Investigator: Nicola Lamberti, PhD
    • Sub-Investigator: Laura Di Marco Pizzongolo, PT, MSc
    • Sub-Investigator: Nino Basaglia, MD
    • Sub-Investigator: Carlotta Martinuzzi, PT
    • Sub-Investigator: Amira Sabbagh Charabati, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• idiopathic Parkinson Disease diagnosis
• age under 80 years
• severity of disease rated 2 or 3 at Hoehn & Yahr scale

Exclusion Criteria:

• impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
• neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
• severe Levodopa dyskinesia
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality; Xbox Kinect + treadmill training	Behavioral: Virtual Reality; 12 sessions of 1 hour (30 min of virtual reality and 30 min of aerobic exercise with treadmill training): three times a week over four weeks
Active Comparator: Conventional Therapy; Specific conventional training for Parkinson's Disease	Behavioral: Conventional Therapy; 12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-Minute Walking Test	The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary.	up to weeks 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	This is an assessment scale of ability to maintain balance, or statically or while performing functional movement, including 14 observable tasks common to everyday life measured on a 5 point ordinal scale.	weeks: 0,4, 16
Time Up and Go Test	Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch.	weeks: 0,4, 16
10 meter walk test	Assesses walking speed in meters per second over a short duration	weeks: 0,4, 16
Unified Parkinson's Disease Rating Scale	It is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease across the longitudinal disease course and provide a clinical endpoint in therapy trials.	weeks: 0,4, 16
Postural sway (Center of pressure (COP) trajectories)	Center of pressure (COP) trajectories	weeks: 0,4, 16
Metabolic measurements by Near infrared spectroscopy	Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks	weeks: 0,4, 16

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Balance; Virtual Reality; Parkinson Disease; Mobility; treadmill training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Body Weight
• Other Study ID Numbers: Parkinson_Xbox

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No