search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Virtual Reality
Conventional Therapy
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Mobility, Balance, Virtual Reality, treadmill training

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ferrara University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality

Conventional Therapy

Arm Description

Xbox Kinect + treadmill training

Specific conventional training for Parkinson's Disease

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
10 meter walk test
Assesses walking speed in meters per second over a short duration
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.
Postural sway (Center of pressure (COP) trajectories)
Center of pressure (COP) trajectories
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

Full Information

First Posted
August 4, 2015
Last Updated
November 16, 2017
Sponsor
University Hospital of Ferrara
search

1. Study Identification

Unique Protocol Identification Number
NCT02516644
Brief Title
Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease
Official Title
Feasibility and Effectiveness of Virtual Reality and the Use of Body Weight Support Treadmill Training in Parkinson's Disease: an Explorative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Mobility, Balance, Virtual Reality, treadmill training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Xbox Kinect + treadmill training
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Specific conventional training for Parkinson's Disease
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional Therapy
Intervention Description
12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks
Primary Outcome Measure Information:
Title
Six-Minute Walking Test
Description
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.
Time Frame
up to weeks 16
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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 Frame
weeks: 0,4, 16
Title
Time Up and Go Test
Description
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.
Time Frame
weeks: 0,4, 16
Title
10 meter walk test
Description
Assesses walking speed in meters per second over a short duration
Time Frame
weeks: 0,4, 16
Title
Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
weeks: 0,4, 16
Title
Postural sway (Center of pressure (COP) trajectories)
Description
Center of pressure (COP) trajectories
Time Frame
weeks: 0,4, 16
Title
Metabolic measurements by Near infrared spectroscopy
Description
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
Time Frame
weeks: 0,4, 16

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Straudi, MD
Phone
+390532238720
Email
s.straudi@ospfe.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD
Organizational Affiliation
Ferrara Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
Phone
0532238720
Email
s.straudi@ospfe.it
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laura Di Marco Pizzongolo, PT, MSc
First Name & Middle Initial & Last Name & Degree
Nino Basaglia, MD
First Name & Middle Initial & Last Name & Degree
Fabio Manfredini, MD
First Name & Middle Initial & Last Name & Degree
Carlotta Martinuzzi, PT
First Name & Middle Initial & Last Name & Degree
Nicola Lamberti, PhD
First Name & Middle Initial & Last Name & Degree
Marco Da Roit, PT
First Name & Middle Initial & Last Name & Degree
Amira Sabbagh Charabati, PT

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs