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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02516644
• Other study ID #: Parkinson_Xbox
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2015
• Last updated: November 16, 2017
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: University Hospital of Ferrara
• Contact: Sofia Straudi, MD
• Phone: +390532238720
• Email: s.straudi[@]ospfe.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Parkinson Disease

Intervention

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
• Conventional Therapy
12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	10 meter walk test	Assesses walking speed in meters per second over a short duration	weeks: 0,4, 16
Secondary	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
Secondary	Postural sway (Center of pressure (COP) trajectories)	Center of pressure (COP) trajectories	weeks: 0,4, 16
Secondary	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