Back to results"VRTierOne" as a Method Supporting the Post-stroke Rehabilitation (VRTierOne)
Primary Purpose
Stroke, Depression
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VR Tier One
Control
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, post-stroke rehabilitation, virtual reality, depression, mental health
Eligibility Criteria
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
Sites / Locations
- Fondazione Ospedale San Camillo IRCCS
- University School of Physical Education
- Rehabilitation Centre "Repty"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VR Tier One
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The Geriatric Depression Scale (GDS)
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.
Generalized Self-Efficacy Scale (GSES)
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.
Acceptance of Illnes Scale (AIS)
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.
The Visual Analogue Scale of Pain (VAS)
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.
Hospital Anxiety and Depression Scale (HADS)
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.
Secondary Outcome Measures
The Barthel Index (BI)
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.
Lawton's Scale
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.
Rivermead Motor Assesment (RMA)
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.
Full Information
NCT ID
NCT03830372
First Posted
February 1, 2019
Last Updated
June 22, 2020
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
National Center for Research and Development, Poland, Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF, IRCCS San Camillo, Venezia, Italy, Foundation for Senior Citizen Activation SIWY DYM
1. Study Identification
Unique Protocol Identification Number
NCT03830372
Brief Title
"VRTierOne" as a Method Supporting the Post-stroke Rehabilitation
Acronym
VRTierOne
Official Title
Evaluation of the Effectiveness of the "VRTierOne" Virtual Therapeutic Game as a Method Supporting the Post-stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
National Center for Research and Development, Poland, Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF, IRCCS San Camillo, Venezia, Italy, Foundation for Senior Citizen Activation SIWY DYM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The goals of the project:
The evaluation of the influence of virtual therapeutic game on the mood and wellbeing of the patients undergoing post-stroke rehabilitation.
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.
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.
The analysis of possible side effects appearing while using virtual reality therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression
Keywords
stroke, post-stroke rehabilitation, virtual reality, depression, mental health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR Tier One
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VR Tier One
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
10 sessions of 20 minutes of Schultz Autogenic Training
Primary Outcome Measure Information:
Title
The Geriatric Depression Scale (GDS)
Description
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.
Time Frame
20 minutes
Title
Generalized Self-Efficacy Scale (GSES)
Description
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.
Time Frame
20 minutes
Title
Acceptance of Illnes Scale (AIS)
Description
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.
Time Frame
10 minutes
Title
The Visual Analogue Scale of Pain (VAS)
Description
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.
Time Frame
3 minute
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
The Barthel Index (BI)
Description
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.
Time Frame
30 minutes
Title
Lawton's Scale
Description
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.
Time Frame
30 minutes
Title
Rivermead Motor Assesment (RMA)
Description
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.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, prof
Organizational Affiliation
University School of Physical Education, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, prof
Organizational Affiliation
University School of Physical Education, Poland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pawel Kiper, PhD
Organizational Affiliation
Fondazione Ospedale San Camillo IRCCS
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione Ospedale San Camillo IRCCS
City
Venice
Country
Italy
Facility Name
University School of Physical Education
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
51-612
Country
Poland
Facility Name
Rehabilitation Centre "Repty"
City
Tarnowskie Góry
State/Province
Śląskie
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24810933
Citation
Li J, Theng YL, Foo S. Game-based digital interventions for depression therapy: a systematic review and meta-analysis. Cyberpsychol Behav Soc Netw. 2014 Aug;17(8):519-27. doi: 10.1089/cyber.2013.0481. Epub 2014 May 8.
Results Reference
background
PubMed Identifier
25093964
Citation
McCann RA, Armstrong CM, Skopp NA, Edwards-Stewart A, Smolenski DJ, June JD, Metzger-Abamukong M, Reger GM. Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. J Anxiety Disord. 2014 Aug;28(6):625-31. doi: 10.1016/j.janxdis.2014.05.010. Epub 2014 Jun 7.
Results Reference
background
PubMed Identifier
28475502
Citation
Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.
Results Reference
background
PubMed Identifier
28325167
Citation
Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22.
Results Reference
background
PubMed Identifier
26491332
Citation
Botella C, Serrano B, Banos RM, Garcia-Palacios A. Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability. Neuropsychiatr Dis Treat. 2015 Oct 3;11:2533-45. doi: 10.2147/NDT.S89542. eCollection 2015.
Results Reference
background
PubMed Identifier
24666248
Citation
Diemer J, Muhlberger A, Pauli P, Zwanzger P. Virtual reality exposure in anxiety disorders: impact on psychophysiological reactivity. World J Biol Psychiatry. 2014 Aug;15(6):427-42. doi: 10.3109/15622975.2014.892632. Epub 2014 Mar 25.
Results Reference
background
PubMed Identifier
24108479
Citation
Motraghi TE, Seim RW, Meyer EC, Morissette SB. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder: a methodological review using CONSORT guidelines. J Clin Psychol. 2014 Mar;70(3):197-208. doi: 10.1002/jclp.22051. Epub 2013 Sep 24.
Results Reference
background
PubMed Identifier
26795129
Citation
Valmaggia LR, Latif L, Kempton MJ, Rus-Calafell M. Virtual reality in the psychological treatment for mental health problems: An systematic review of recent evidence. Psychiatry Res. 2016 Feb 28;236:189-195. doi: 10.1016/j.psychres.2016.01.015. Epub 2016 Jan 12.
Results Reference
background
PubMed Identifier
19361298
Citation
Tsirlin I, Dupierrix E, Chokron S, Coquillart S, Ohlmann T. Uses of virtual reality for diagnosis, rehabilitation and study of unilateral spatial neglect: review and analysis. Cyberpsychol Behav. 2009 Apr;12(2):175-81. doi: 10.1089/cpb.2008.0208.
Results Reference
background
PubMed Identifier
29372007
Citation
Rizzo A', Shilling R. Clinical Virtual Reality tools to advance the prevention, assessment, and treatment of PTSD. Eur J Psychotraumatol. 2017 Jan 16;8(sup5):1414560. doi: 10.1080/20008198.2017.1414560. eCollection 2017.
Results Reference
background
PubMed Identifier
26923937
Citation
Negut A, Matu SA, Sava FA, David D. Virtual reality measures in neuropsychological assessment: a meta-analytic review. Clin Neuropsychol. 2016 Feb;30(2):165-84. doi: 10.1080/13854046.2016.1144793. Epub 2016 Feb 29.
Results Reference
background
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"VRTierOne" as a Method Supporting the Post-stroke Rehabilitation
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