"VRTierOne" as a Method Supporting the Post-stroke Rehabilitation (VRTierOne)

June 22, 2020 updated by: Joanna Szczepańska-Gieracha, University School of Physical Education in Wroclaw

Evaluation of the Effectiveness of the "VRTierOne" Virtual Therapeutic Game as a Method Supporting the Post-stroke Rehabilitation

Thanks to using VR googles and the phenomenon of total immersion "VR Tier One" allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the game, it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goals of the project:

  1. The evaluation of the influence of virtual therapeutic game on the mood and wellbeing of the patients undergoing post-stroke rehabilitation.
  2. The evaluation of the influence of virtual therapeutic game on the acceptance of the illness and self-efficacy assessment of the patients undergoing post-stroke rehabilitation.
  3. The evaluation of the influence of virtual therapeutic game on the effectiveness of post-stroke rehabilitation process in relation to locomotive function as well as basic and instrumental activities of daily living.
  4. The analysis of possible side effects appearing while using virtual reality therapy.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Venice, Italy
        • Fondazione Ospedale San Camillo IRCCS
  • Poland
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 51-612
        • University School of Physical Education
    • Śląskie
      • Tarnowskie Góry, Śląskie, Poland
        • Rehabilitation Centre "Repty"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ischemic stroke
  • depression symptoms scored 10 and more in Geriatric Depression Scale (GDS-30)

Exclusion Criteria:

  • cognitive functions (MMSE<24)
  • epilepsy,
  • vertigo,
  • aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE,
  • presence at the time of the examination or in the medical data: mental retardation, disturbances of consciousness or other serious mental disorders,
  • patient's refusal at any stage of the research project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR Tier One

Patients will receive:

  • 10 sessions of 20 minutes of VR Tire One therapeutic game,
  • 60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,
  • 30 minutes individual aerobic training,
  • 30 minutes balance exercises.
Device: VR Tier One

10 sessions of 20 minutes virtual terapeutic game

Thanks to using VR googles and the phenomenon of total immersion VR Tier One terapy game allows to completely separate the patient from the hospital environment and provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms.
Active Comparator: Control

Patients will receive:

  • 10 sessions of 20 minutes of Schultz Autogenic Training,
  • 60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,
  • 30 minutes individual aerobic training,
  • 30 minutes balance exercises.
Other: Control
10 sessions of 20 minutes of Schultz Autogenic Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 15 minutes
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
15 minutes
The Geriatric Depression Scale (GDS)
Time Frame: 20 minutes
The Geriatric Depression Scale is a self-report 30-items measure of well-being and mood in older adults. The patient responds in a "Yes/No" format. Scoring ranges from 0 to 30, where 11 and more means mood disorders. The higher score means the greater depression. GDS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
20 minutes
Generalized Self-Efficacy Scale (GSES)
Time Frame: 20 minutes
Generalized Self - Efficacy Scale consists of 10 statements. In each question, the patient can get 4 points. The scale measures the strength of the general belief of the individual about the effectiveness of coping with difficult situations and unexpected events as well as determination in pursuing the goal. Scoring ranges from 10 to 40 points. The more points the patient gets, the better he assesses his effectiveness in dealing with problems. The GSES will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
20 minutes
Acceptance of Illnes Scale (AIS)
Time Frame: 10 minutes
Acceptance of Illness Scale contains eight statements describing the consequences of poor health. Scoring is in the range of 8 to 40 points. A small number of points means no acceptance of the disease and a strong sense of mental discomfort, while a high score means adaptation to the situation and lack of negative emotions associated with the disease. The AIS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
10 minutes
The Visual Analogue Scale of Pain (VAS)
Time Frame: 3 minute
The Visual Analogue Scale of Pain is a psychometric measurement for intensity of pain, assesses the pain sensation on a scale of 0 to 10, where 0 means no pain and 10 means unbearable pain. The VAS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
3 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Barthel Index (BI)
Time Frame: 30 minutes
Barthel Index is a method of assessing the basic activities of daily living. Scoring ranges from 0 to 100, where 100 means full independence in basic activities (self-dressing, undressing, washing, use of the toilet, eating meals, transferring from a bed to a chair etc.). The score below 20 means the need for round the clock care. BI will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
30 minutes
Lawton's Scale
Time Frame: 30 minutes
Lawton's Scale assesses the instrumental activity of daily living such as using a telephone, shopping, preparing meals, household duties, washing clothes, money managing etc. The scale contains eight questions about the instrumental activities of everyday life which the patient can do without help, with a little help or is not able to do it at all. Scoring ranges from 8 to 24. The more points the more independent the patient is. The Lawton's Scale will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
30 minutes
Rivermead Motor Assesment (RMA)
Time Frame: 30 minutes
The Rivermead Motor Assesment measures mobility and locomotion (e.g. changing positions, transfers, walking up stairs, etc.). 13 tasks are assessed, for each of them the patient may receive one point. The higher the score, the greater the mobility of the subject. The Rivermead Mobility Index will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University School of Physical Education in Wroclaw

Collaborators

IRCCS San Camillo, Venezia, Italy
National Center for Research and Development, Poland
Foundation for Senior Citizen Activation SIWY DYM
Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF

Investigators

  • Study Chair: Pawel Kiper, PhD, Fondazione Ospedale San Camillo IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Actual)

April 3, 2020

Study Completion (Actual)

April 3, 2020

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POIR.01-02.00-00-0134/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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