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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Dolphin 2.0
Sponsored by
Campus Neurológico Sénior
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Campus Neurológico Sénior

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active arm

Delayed-start control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time reduction in seconds in the TUG test (late intervention effect)
Late intervention effect: superiority of active group versus control group with respect to TUG result at 12 and 16-weeks
Change in MDS-UPDRS
Difference between groups in MDS-UPDRS
Change in Mini-best test
Difference between groups in Mini-best test
Change in SCOPA-Cog
Difference between groups in SCOPA-Cog
Change in PDQ-39 score
Difference between groups in PDQ-39 score
Change in Clinical Global Improvement
Difference between groups in Clinical Global Improvement
Change in Patient Global Impression - Change
Difference between groups in Patient Global Impression - Change
System Usability Scale
Difference between groups in System Usability Scale
Simulator Sickness Questionnaire
Difference between groups in Simulator Sickness Questionnaire
Number of steps/day
Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)
Time spent in each level of activity
Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)
Change in BMI
Difference between groups in BMI
Change in Schwab and England scale
Difference between groups in Schwab and England scale
Patients' satisfaction and perceived exertion
Difference between groups in Patients' satisfaction and perceived exertion (7-points Likert scale)

Full Information

First Posted
January 4, 2021
Last Updated
August 14, 2023
Sponsor
Campus Neurológico Sénior
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04699617
Brief Title
The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients
Official Title
The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Campus Neurológico Sénior
Collaborators
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.
Masking
Outcomes Assessor
Masking Description
single-blind (blind rater for primary and secondary outcomes)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed-start control arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dolphin 2.0
Intervention Description
The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.
Primary Outcome Measure Information:
Title
Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect)
Description
Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks
Time Frame
6-weeks (T1)
Secondary Outcome Measure Information:
Title
Time reduction in seconds in the TUG test (late intervention effect)
Description
Late intervention effect: superiority of active group versus control group with respect to TUG result at 12 and 16-weeks
Time Frame
12-weeks (T2) and 16-weeks (T3)
Title
Change in MDS-UPDRS
Description
Difference between groups in MDS-UPDRS
Time Frame
Baseline, 6-week, 12-week and 16-week
Title
Change in Mini-best test
Description
Difference between groups in Mini-best test
Time Frame
Baseline, 6-week, 12-week and 16-week
Title
Change in SCOPA-Cog
Description
Difference between groups in SCOPA-Cog
Time Frame
at baseline and 16-week
Title
Change in PDQ-39 score
Description
Difference between groups in PDQ-39 score
Time Frame
at baseline and and 12-week
Title
Change in Clinical Global Improvement
Description
Difference between groups in Clinical Global Improvement
Time Frame
Baseline, 6-week, 12-week and 16-week
Title
Change in Patient Global Impression - Change
Description
Difference between groups in Patient Global Impression - Change
Time Frame
Baseline, 6-week, 12-week and 16-week
Title
System Usability Scale
Description
Difference between groups in System Usability Scale
Time Frame
after the 1st session of 1st week and the last sessions of 6th and 12th weeks
Title
Simulator Sickness Questionnaire
Description
Difference between groups in Simulator Sickness Questionnaire
Time Frame
after the 1st session of 1st week and the last sessions of 6th and 12th weeks
Title
Number of steps/day
Description
Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)
Time Frame
Baseline, 6-week, 12-week and 16-week
Title
Time spent in each level of activity
Description
Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)
Time Frame
Baseline, 6-week, 12-week and 16-week
Title
Change in BMI
Description
Difference between groups in BMI
Time Frame
Baseline, 6-week, 12-week and 16-week
Title
Change in Schwab and England scale
Description
Difference between groups in Schwab and England scale
Time Frame
at baseline and 12-week
Title
Patients' satisfaction and perceived exertion
Description
Difference between groups in Patients' satisfaction and perceived exertion (7-points Likert scale)
Time Frame
after the 1st session of 1st week and the last sessions of 6th and 12th weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim Ferreira, MD,PhD
Organizational Affiliation
CNS - Campus Neurológico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Neurológico Sénior
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The methodology followed and the results of the study will be shared at the end through publication in a peer-review journal

Learn more about this trial

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

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