The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients

NCT04699617 | Completed

• 1 other identifier: CNS2021-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures (dolphin, orca, axolotl). Video games lead to high levels of motivation and arousal, provide immediate feedback and playback, provide explicit reward and implicit success, and titrate difficulty levels. This encourages the practice of exercise, being an important complement to physiotherapy sessions. The main goal of this study is to evaluate the feasibility, safety and efficacy of an immersive virtual reality software (Dolphin, 2.0) in Parkinson's disease symptomatic control, in a two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect)

  Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks

  6-weeks (T1)

Secondary Outcomes (14)

• Time reduction in seconds in the TUG test (late intervention effect)

  12-weeks (T2) and 16-weeks (T3)

• Change in MDS-UPDRS

  Baseline, 6-week, 12-week and 16-week

• Change in Mini-best test

  Baseline, 6-week, 12-week and 16-week

• Change in SCOPA-Cog

  at baseline and 16-week

• Change in PDQ-39 score

  at baseline and and 12-week

Study Arms (2)

Active arm

EXPERIMENTAL

The active arm will include 3 days a week of training with the Dolphin 2.0 for 12 consecutive weeks. Each session will have the duration of 60 minutes.

Device: Dolphin 2.0

Delayed-start control arm

ACTIVE COMPARATOR

The delayed-start control arm will have six-weeks of physiotherapy specialized for PD (3 times/week, 60 minutes/session) and six-weeks of 3 days a week of training with the Dolphin 2.0, with sessions of 60 minutes.

Device: Dolphin 2.0

Interventions

Dolphin 2.0 DEVICE

The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.

Active arm; Delayed-start control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Parkinson's disease according to MDS criteria;
• Hoehn and Yahr stages between I-III (MED ON);
• Ability to perform the Time Up and Go test in normal pace and without assistance, in less than 11,5 seconds in ON state;
• Stable medication for the past 1 month
• Ability to communicate with the investigator, to understand and comply with the requirements of the study;
• Willing and able to provide written informed consent to participate in the study.

You may not qualify if:

• History of falls (1 fall in the 3 previous months);
• Psychiatric major co-morbidity (e.g., major depressive disorder as determined by DSM IV criteria);
• A Montreal Cognitive Assessment (MoCA) score \< 21;
• Significant visual or visual-perceptual deficits or neuropsychological impairments that may limit participation in the protocol;
• Having any other neurological/orthopaedic disorders likely to affect gait or exercise capacity, e.g., history of stroke;
• Unstable medical condition including cardiovascular instability in the past 6 months
• Interfering activities performed at high level (sports);
• Inability to correctly respond to the assessment protocol according to the clinician's judgment or lack of support from caregiver for this effect.

Sponsors & Collaborators

• Campus Neurológico Sénior: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Campus Neurológico Sénior

Torres Vedras, 2560-280, Portugal

Location

Related Publications (3)

• Pimenta Silva D, Bouca-Machado R, Pona-Ferreira F, Lobo T, Cacho R, Anker R, Krakauer JW, Ferreira JJ. Combining immersive exergaming with physiotherapy in a specialized intensive Parkinson's disease rehabilitation program: a randomized controlled trial. J Neuroeng Rehabil. 2025 Jun 11;22(1):131. doi: 10.1186/s12984-025-01640-w.

  PMID: 40500714 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. 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

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

• Joaquim Ferreira, MD,PhD

  CNS - Campus Neurológico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single-blind (blind rater for primary and secondary outcomes)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: December 28, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)