Virtual Reality in Parkinson Disease (VRPark)

February 11, 2017 updated by: Costanza Pazzaglia, Fondazione Don Carlo Gnocchi Onlus

To Rehabilitate With Virtual Reality: To Evaluate the Effect of Virtual Reality on Cardiocirculatory System and on Balance in a Sample of Healthy Subject and Patients Affected by Parkinson Disease

Patients affected by Parkinson disease (PD) can benefit from rehabilitation although the evidences are scattered. In the last years there are increased evidences that virtual reality can improve functional outcome in Parkinson's disease. No evidences are known concerning the cardiological safety and effect on balance of Virtual Reality. The aim of this study is to compare a virtual reality rehabilitation program versus a conventional one in a sample of patients affected by mild to moderate Parkinson and to collect data on cardiological effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective, single-blinded, randomized controlled trial aimed to compare two different rehabilitation programs in PD disease and to evaluate the effect of Virtual Reality on cardiocirculatory system.

Patients will undergo Conventional or Virtual Reality Rehabilitation Program for 6 consecutive weeks, 3-times in a week for a 40 minute session. Moreover, in order to acquire data on cardiocirculatory system during the first and the last sessions an Holter- electrocardiography will be used. Data will be compared with healthy subjects (matched for age and gender).

The used protocols are reported below.

Conventional (C) Rehabilitation Program The Conventional rehabilitation program will be performed according to the " Royal Dutch Society for Physical Therapy Guidelines for physical therapy in patients with Parkinson's disease". In each C rehabilitation session, patients will undergo 3 phases: 1) Warm-up phase: passive mobilization of main joints and muscular strengthen of lower limbs; 2) Active phase (both standing than seated): exercises of motor coordination with upper and lower limbs, balance training, start and stop exercises, deambulation training; 3) cool-down phase (with seated patient): manipulation exercises, mobilization exercises, respiratory exercises.

Virtual Reality (VR) Rehabilitation Program Each session will consist of multiple exercises. These ones are described below, each exercise will be performed by the patient for 4 minutes followed by a 1 minute of rest.

Exercise 1 (named Trumpet H2D1): patients placed in the center of the room and asked to randomly touch a moving trumpet displayed on the wall screen. When the trumpet will be reached by patient's arm, it will disappear giving out a sound.

Exercise 2 (named Pink rose hemiarch left and right H1D2): patients placed in the center of the room and asked to touch the rose projected on the wall screen as a hemiarch, in this exercise the sequence of rose to touch and therefore the distance between the target and the patient will be decided by the physical therapist.

Exercise 3 (named Doggy): patients placed in the center of the room and asked to lead a dog in the four corner of the wall screen. Patients will be free to move in the room.

Exercise 4 (named Eggs): patients placed in the center of the room and asked to touch as fast as possible eggs projected in the wall screen in a random order. When the egg will be reached by patient's arm, it will disappear giving out a sound.

Exercise 5 (named Mole): patients placed in the center of the room and asked to reach a mole that will go out from a hole. The patients will know where the mole will be and they will move in the room. When the mole will be reached by patient's arm, it will disappear giving out a sound.

Exercise 6 (named Stay Or Move In Between): patients placed in the center of the room and wre asked to perform the motor task as indicated by physical therapist while maintaining balance between two lateral bars in order not to touch them and not make them sound.

Exercise 7 (named Leaves): patients placed in the center of the room and asked to clean from wall screen as fast as possible all the leaves projected in the wall.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Don carlo Gnocchi Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients affected by mild to moderate PD, according to motor examination section (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS III)
  • ability to independently perform motor rehabilitation
  • absence of cognitive impairment (MMSE >25)

Exclusion Criteria:

  • severe hearing loss and/or visual deficit
  • serious comorbidity making impossible to perform rehabilitation (postural hypotension, heart disease, stroke, severe shoulder-hip disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
Patients will be treated with a virtual reality rehabilitation program
Other: Virtual reality
Each session will consist of multiple exercises. These ones are already described, each exercise will be performed by the patient for 4 minutes followed by a 1 minute of rest.
Other Names:
  • VR rehabilitation group
Other: Conventional Rehabilitation Program
Patients will be treated with a conventional rehabilitation program.
Other: Conventional rehabilitation program
In each C rehabilitation session, patients underwent 3 phases: 1) Warm-up phase: passive mobilization of main joints and muscular strengthen of lower limbs; 2) Active phase (both standing than seated): exercises of motor coordination with upper and lower limbs, balance training, start and stop exercises, deambulation training; 3) cool-down phase (with seated patient): manipulation exercises, mobilization exercises, respiratory exercises.
Other Names:
  • C rehabilitation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Balance Berg Scale (BBS)
Time Frame: Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks
It is a 14-item scale that rates each function from 0 (worst) to 4 (best) along a dependence-independence continuum. This summative scale measures balance abilities seen during tasks involving sitting, standing, and positional changes. Total scores are indicative of overall balance abilities, with scores interpreted in the following manner: 0 to 20, wheelchair bound; 21 to 40, walking with assistance; and 41 to 56, independent.This scale has been previously validated in PD patients
Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Dynamic gait index (DGI)
Time Frame: Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks
is an outcome measure used to characterize mobility performance, specifically the ability to adapt gait to complex walking tasks associated with walking in community environments. The index has 8 items, the results are reported in a four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. The total score is 24. A result less than 19/24 is predictive of falls in the elderly, while a result more than 22/24 means safe ambulation.
Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks
Change from Baseline Disabilities of the arm, shoulder and hand scale (DASH)
Time Frame: Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks
is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The higher the score, the higher the function.
Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Study Chair: Isabella Imbimbo, MPC, Fondazione Don Carlo Gnocchi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 11, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. n.5/2016/CE_FdG/SA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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