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Virtual Reality in Parkinson Disease (VRPark)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Costanza Pazzaglia, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier:
NCT02807740
First received: May 31, 2016
Last updated: February 11, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Parkinson Disease
Other: Virtual reality
Other: Conventional rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fondazione Don Carlo Gnocchi Onlus:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 30
Study Start Date: May 2016
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: VR rehabilitation group
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 Name: C rehabilitation group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02807740

Locations
Italy
Don Carlo Gnocchi Foundation
Rome, Italy, 00168
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Investigators
Study Chair: Isabella Imbimbo, MPC Fondazione Don Carlo Gnocchi
  More Information

Publications:
Responsible Party: Costanza Pazzaglia, Researcher, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02807740     History of Changes
Other Study ID Numbers: Prot. n.5/2016/CE_FdG/SA 
Study First Received: May 31, 2016
Last Updated: February 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Fondazione Don Carlo Gnocchi Onlus:
Virtual Reality
Rehabilitation
Cardiocirculatory system
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on February 20, 2017