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

NCT ID: NCT02516644

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Parkinson Disease

Keywords

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Parkinson Disease Mobility Balance Virtual Reality treadmill training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual reality

Xbox Kinect + treadmill training

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

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

Specific conventional training for Parkinson's Disease

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Conventional Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sofia Straudi, MD

Role: PRINCIPAL_INVESTIGATOR

Ferrara Rehabilitation Hospital

Locations

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Ferrara University Hospital

Ferrara, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Sofia Straudi, MD

Role: CONTACT

Phone: +390532238720

Email: [email protected]

Facility Contacts

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Sofia Straudi, MD, PhD

Role: primary

Other Identifiers

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Parkinson_Xbox

Identifier Type: -

Identifier Source: org_study_id