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

NCT02516644 | Unknown DMC

• 1 other identifier: Parkinson_Xbox
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Mobility; Balance; Virtual Reality; treadmill training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Berg Balance Scale

  weeks: 0,4, 16

• Time Up and Go Test

  weeks: 0,4, 16

• 10 meter walk test

  weeks: 0,4, 16

• Unified Parkinson's Disease Rating Scale

  weeks: 0,4, 16

• Postural sway (Center of pressure (COP) trajectories)

  weeks: 0,4, 16

Study Arms (2)

Virtual reality

EXPERIMENTAL

Xbox Kinect + treadmill training

Behavioral: Virtual Reality

Conventional Therapy

ACTIVE COMPARATOR

Specific conventional training for Parkinson's Disease

Behavioral: Conventional Therapy

Interventions

Virtual Reality 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

Virtual reality

Conventional Therapy BEHAVIORAL

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

Conventional Therapy

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sofia Straudi, MD

  Ferrara Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Straudi, MD

CONTACT

+390532238720; s.straudi@ospfe.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 6, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)