Virtual Reality in Parkinson Disease

NCT02807740 | Completed

• 1 other identifier: Prot. n.5/2016/CE_FdG/SA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Virtual Reality; Rehabilitation; Cardiocirculatory system; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks

Secondary Outcomes (2)

• Change from Baseline Dynamic gait index (DGI)

  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)

  Patients will be evaluated at baseline (T0) and at the end of each rehabilitation program (T1), lasting 6 weeks

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Patients will be treated with a virtual reality rehabilitation program

Other: Virtual reality

Conventional Rehabilitation Program

OTHER

Patients will be treated with a conventional rehabilitation program.

Other: Conventional rehabilitation program

Interventions

Virtual reality OTHER

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.

Also known as: VR rehabilitation group

Virtual Reality

Conventional rehabilitation program OTHER

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.

Also known as: C rehabilitation group

Conventional Rehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Carlo Gnocchi Foundation

Rome, Italy, 00168, Italy

Location

Related Publications (5)

• 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.

  PMID: 26360239 RESULT

• 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.

  PMID: 24132848 RESULT

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• 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.

  PMID: 32026844 DERIVED

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

• Isabella Imbimbo, MPC

  Fondazione Don Carlo Gnocchi

  STUDY CHAIR

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: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 21, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)