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

Not Applicable

• Conditions: Parkinson Disease

• Registration Number: NCT02516644
• Lead Sponsor: University Hospital of Ferrara

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Six-Minute Walking Test	up to weeks 16	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.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	weeks: 0,4, 16	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.
Time Up and Go Test	weeks: 0,4, 16	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.
10 meter walk test	weeks: 0,4, 16	Assesses walking speed in meters per second over a short duration
Unified Parkinson's Disease Rating Scale	weeks: 0,4, 16	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.
Postural sway (Center of pressure (COP) trajectories)	weeks: 0,4, 16	Center of pressure (COP) trajectories
Metabolic measurements by Near infrared spectroscopy	weeks: 0,4, 16	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

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, Italy