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Virtual Reality in Parkinson Disease (VRPark)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Virtual reality
Conventional rehabilitation program
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Virtual Reality, Rehabilitation, Cardiocirculatory system, Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Don Carlo Gnocchi Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Virtual Reality

Conventional Rehabilitation Program

Arm Description

Patients will be treated with a virtual reality rehabilitation program

Patients will be treated with a conventional rehabilitation program.

Outcomes

Primary Outcome Measures

Change from Baseline Balance Berg Scale (BBS)
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

Secondary Outcome Measures

Change from Baseline Dynamic gait index (DGI)
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.
Change from Baseline Disabilities of the arm, shoulder and hand scale (DASH)
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.

Full Information

First Posted
May 31, 2016
Last Updated
February 11, 2017
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT02807740
Brief Title
Virtual Reality in Parkinson Disease
Acronym
VRPark
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Virtual Reality, Rehabilitation, Cardiocirculatory system, Parkinson Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Patients will be treated with a virtual reality rehabilitation program
Arm Title
Conventional Rehabilitation Program
Arm Type
Other
Arm Description
Patients will be treated with a conventional rehabilitation program.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Other Intervention Name(s)
VR rehabilitation group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation program
Other Intervention Name(s)
C rehabilitation group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Balance Berg Scale (BBS)
Description
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
Time Frame
Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Dynamic gait index (DGI)
Description
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.
Time Frame
Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks
Title
Change from Baseline Disabilities of the arm, shoulder and hand scale (DASH)
Description
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.
Time Frame
Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Imbimbo, MPC
Organizational Affiliation
Fondazione Don Carlo Gnocchi
Official's Role
Study Chair
Facility Information:
Facility Name
Don Carlo Gnocchi Foundation
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26360239
Citation
Abbruzzese G, Marchese R, Avanzino L, Pelosin E. Rehabilitation for Parkinson's disease: Current outlook and future challenges. Parkinsonism Relat Disord. 2016 Jan;22 Suppl 1:S60-4. doi: 10.1016/j.parkreldis.2015.09.005. Epub 2015 Sep 3.
Results Reference
result
PubMed Identifier
24132848
Citation
Mirelman A, Maidan I, Deutsch JE. Virtual reality and motor imagery: promising tools for assessment and therapy in Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1597-608. doi: 10.1002/mds.25670.
Results Reference
result
PubMed Identifier
32026844
Citation
Pazzaglia C, Imbimbo I, Tranchita E, Minganti C, Ricciardi D, Lo Monaco R, Parisi A, Padua L. Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial. Physiotherapy. 2020 Mar;106:36-42. doi: 10.1016/j.physio.2019.12.007. Epub 2019 Dec 23.
Results Reference
derived

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Virtual Reality in Parkinson Disease

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