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Clinical Trials/NCT02516644
NCT02516644UnknownNot Applicable

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

University Hospital of Ferrara2 sites in 1 country20 target enrollmentStarted: February 1, 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Six-Minute Walking Test
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
— to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Virtual reality

Experimental

Xbox Kinect + treadmill training

Intervention: Virtual Reality (Behavioral)

Conventional Therapy

Active Comparator

Specific conventional training for Parkinson's Disease

Intervention: Conventional Therapy (Behavioral)

Outcomes

Primary Outcomes

Six-Minute Walking Test

Time Frame: 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 Outcomes

  • 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)
  • Metabolic measurements by Near infrared spectroscopy(weeks: 0,4, 16)

Investigators

Sponsor
University Hospital of Ferrara
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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