Disability PhysicalNCT04402034
Telerehabilitation in Disabled People: Proposal for Practical Intervention With Virtual Reality
A study testing Application of tele-rehabilitation in people with Disability Physical, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This is a cross-sectional study, that is going to be conducted during the quarantine, period established by the state of São Paulo to reduce the transmission of COVID-19, between March 24 2020 and May 31 2020. Read more about this study
- Who is it for?
- Ages 7 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Disability Physical
- What is being tested?
- Application of tele-rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 15 May 2020to 21 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- agreement to participate
- clinical diagnosis of the disease
- age ranging from 7 to 80 years old
Who cannot join
- do not understand the tasks
- motor difficulties that impede the completing of the virtual tasks
- do not have technology devices to perform the virtual task (computer) or to contact the researcher (cell phone or a second computer)
- was precluded from completing the task due to some technological failure (such as internet crash).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
São Paulo, 03828-000
About this study
This is a cross-sectional study, that is going to be conducted during the quarantine, period established by the state of São Paulo to reduce the transmission of COVID-19, between March 24 2020 and May 31 2020. Thus, the differential of this study is to use 100% telerehabilitation, in which the rehabilitation team and participants only had telephone contact, communication application (WhatsApp) and software interaction. 40 participants will be included. Potential and interested volunteers will be assessed by a detailed screening using the eligibility criteria and attended an initial selection for enrolment in the study. It wiil be used a platform called MoveHero, available for free use in https://movehero.com.br/. The individual needs access the internet, and once he gets online, he had to create his own account, inserting his name, email and creating a password. Considering that the platform presents different levels of difficulty, after the participant is connected to the platform, the researcher directed the participant to the protocol bespoke for each participant, playing 3 rounds of the game for 5 minutes each (total of 15 minutes). During the intervention, it will be applied BORG scale in order to assess their perceived effort.
Read the detailed description
Instrument In this study, it will be used a platform called MoveHero, available for free use in https://movehero.com.br/. The individual needs access the internet, and once he gets online, he had to create his own account, inserting his name, email and creating a password. Considering that the platform presents different levels of difficulty, after the participant is connected to the platform, the researcher directed the participant to the protocol specially developed for cerebral palsy. MoveHero is considerate a timing coincident task and present several spheres falling down on the computer screen, with a musical rhythm to increase engagement. Thus, the participants will be positioned in front of a computer and when the game started the webcam captures the participant movements and a representation of the players appears on the computer screen as an avatar. The game goals are to intercept all falling spheres using upper limb wave movements in the exact moment the spheres reached their specific target in the bottom of computer screen. The game presented four columns with fixed targets in parallel allocated in two height levels (e.g. two on the left - targets A and B; two on the right - targets C and D). The game provides hit and miss feedback - if the individual reaches the spheres correctly, the game presented a feedback with the spheres changing the color for green (hit information). On the other hand, if the participant do not touch the spheres properly, the spheres changing the color for red and the letter X appears inside the target (miss information).
Software score During the game match (each game match lasts for 5 minutes) the participant can follow the score determined by the number of spheres hit (i.e. the information from each sphere hit appears in the bottom left side of the screen all the time) and at the end of each game match the participant had feedback with their total score (when the game match finished a total score appears in the middle of the computer screen). The game features 10 different and progressive phases of difficulty, considering the number of balls falling. In this study, all participants will start at the easiest phase (phase 1) and according to their own score, the researcher should move forward to a more difficult phase. The progression in the phase was established by the table below. Thus, each participant presents an individual progression, considering their performance.
Assessments
To characterize the participants it will be used some scales that characterize each disease and can be applied such as Pediatric Evaluation of Disability Inventory (PEDI) for children and Quality of Life and specific scales for adults. As well as sociodemographic Information: some questions will be asked, such as age, sex, income to understand the studied population.
To analyse the outcome Measures will be used: 1) Brunel Mood Scale (BRUMS) measures six identifiable affective states (Tension, Depression, Anger, Vigor, Fatigue, and Confusion) through a 24-item self-report inventory, with respondents rating a list of adjectives on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely), based on subjective feelings. The instructions refer to how participants have been feeling in the past week, including today. 2) BORG scale: is Rating of Perceived Exertion used to measure the subjective intensity of effort. It is based on the sensations felt during exercise, such as muscle fatigue, increased heart rate and increased breathing. 3) System Usability Scale (SUS), was proposed by John Brooke in 1986 as the usability test tool. It is a simple scale based on a questionnaire and has been widely adopted in product usability evaluations. The statements cover a variety of aspects of system usability such as the need for support, training, and complexity, and thus have a high level of face validity for measuring usability of a system. The SUS instrument is generally used after the respondent has had an opportunity to use the system being evaluated. This instrument is a highly robust and versatile tool for usability professionals.
1.5 Procedure and Design
Contact and assessment scales
The parent's individuals (for children) or the individual itself will be contacted by phone and asked to perform the task at home, they will be assisted by the researcher over the phone, with a video call. Important to emphasized that all participants that need assistance, will be assisted by their parents or their caregivers. First, they wiil receive a link with research information and the assent and consent form to fill out and the inclusion criteria will be checked by researcher. When they agree to participate, a link to access a questioner will be sent with Brunel Mood Scale, BORG scale, PEDI and Sociodemographic Information. When parents and participants finish those scales the gaming platform will be accessed and the participant starts the protocol practice.
Practicing the task
Participants will perform the task individually in their own house with a family member helping and giving support during all protocol. The researcher contacts the family member and gives the following instructions using videocall (research interact with the family member and the participant during all the protocol): 1) place the computer on a table and login to the platform; 2) position the cell phone (to provide videocall) on the side of the computer to receive instructions; 3) provide a comfortable sitting position in a chair (individual should be positioned at a distance of approximately 1.5 m meters from the computer monitor) and adjusted in height according to the needs of the individual (if applicable, participants could use their own wheelchair); 4) after being seated and connected to the platform the research will explain the task verbally for all participants and ask the family member to play ones (demonstrations of how to perform the coincidence timing was given form the family member during two minutes); 5) after demonstration, the family member should grab the mobile phone (to have the opportunity to move the phone and show the participant performance to the researcher during all the protocol) and 6) thus, the therapist (by video call) instructed the participant to stay still and wait the first sphere appears on the screen. Once the first sphere appears, the individual had to move his or her hand to either touch the sphere exactly at the moment coinciding with the bottom target and the game should move on with different spheres falling in the computer screen.
Protocol
As presented before the parent and participant should answer 4 assessments (Brunel Mood Scale, BORG scale, PEDI and Demographic Information), and start to perform the first game phase (phase 1), after 5 minutes playing the game the participant will answer the Borg scale and researcher will analyze the game score (e.g. according to table 2 the participant should repeat phase one or move forward for a more difficult phase); the participant started a second practice and after 5 minutes answer the Borg scale (again- the participant should repeat last phase or move forward for a more difficult phase); the participant started a third and last practice and after 5 minutes had to answer the Borg scale and to finish the protocol the BRUMS scale and the System Usability Scale (SUS).
- Conditions
- Disability Physical
- Being tested
- Application of tele-rehabilitation
- Keywords
- Disability Physical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of tele-rehabilitationBehavioural
Individuals that will perform the virtual reality intervention.
| Study group | Role | What they receive |
|---|---|---|
| Application of tele-rehabilitation | Experimental | Individuals that will perform the protocol of virtual reality intervention. Receives: Behavioral: Application of tele-rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance.
The motor performance will be measured by the virtual game "MoveHero", which gives data about accuracy, precision and directional trend of movement.
Measured: 1 day
Secondary outcomes (1)
Perceived Exertion.
The Perceived Exertion will me assessed by the Borg Rating of Perceived Exertion (RPE), based on a 6 to 20 rating scale, in which a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort.
Measured: 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start15 May 2020
- Primary completion20 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402034
- Sponsor's protocol ID
- 03851012.7.0000.5390
- Status last verified
- Oct 2020
- First submitted
- 20 May 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almeida AFS, Silva TDD, Moraes IAP, Menezes LDC, Dias ED, Araujo LV, Monteiro CBM, Dawes H, Simcsik AO, Alberissi CAO, Silva VYHD, Brunherotti MAA, Tonello MGM. Virtual reality as a telerehabilitation strategy for people with autism spectrum disorder during the COVID-19 quarantine scenario: physical activity, motor performance and enjoyment. Disabil Rehabil Assist Technol. 2024 Jul;19(5):2046-2056. doi: 10.1080/17483107.2023.2249031. Epub 2023 Sep 11.
PubMed 37695272da Silva TD, da Silva PL, Valenzuela EJ, Dias ED, Simcsik AO, de Carvalho MG, Fontes AMGG, Alberissi CAO, de Araujo LV, Brandao MVDC, Dawes H, Monteiro CBM. Serious Game Platform as a Possibility for Home-Based Telerehabilitation for Individuals With Cerebral Palsy During COVID-19 Quarantine - A Cross-Sectional Pilot Study. Front Psychol. 2021 Feb 2;12:622678. doi: 10.3389/fpsyg.2021.622678. eCollection 2021.
PubMed 33633648
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation in Disabled People: Proposal for Practical Intervention With Virtual Reality
- ClinicalTrials.gov ID
- NCT04402034
- Acronym / sponsor ID
- 03851012.7.0000.5390
- Conditions
- Disability Physical
- Keywords
- Disability Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional study, that is going to be conducted during the quarantine, period established by the state of São Paulo to reduce the transmission of COVID-19, between March 24 2020 and May 31 2020. Thus, the differential of this study is to use 100% telerehabilitation, in which the rehabilitation team and participants only had telephone contact, communication application (WhatsApp) and software interaction. 40 participants will be included. Potential and interested volunteers will be assessed by a detailed screening using the eligibility criteria and attended an initial selection for enrolment in the study. It wiil be used a platform called MoveHero, available for free use in https://movehero.com.br/. The individual needs access the internet, and once he gets online, he had to create his own account, inserting his name, email and creating a password. Considering that the platform presents different levels of difficulty, after the participant is connected to the platform, the researcher directed the participant to the protocol bespoke for each participant, playing 3 rounds of the game for 5 minutes each (total of 15 minutes). During the intervention, it will be applied BORG scale in order to assess their perceived effort.
Detailed description
Instrument In this study, it will be used a platform called MoveHero, available for free use in https://movehero.com.br/. The individual needs access the internet, and once he gets online, he had to create his own account, inserting his name, email and creating a password. Considering that the platform presents different levels of difficulty, after the participant is connected to the platform, the researcher directed the participant to the protocol specially developed for cerebral palsy. MoveHero is considerate a timing coincident task and present several spheres falling down on the computer screen, with a musical rhythm to increase engagement. Thus, the participants will be positioned in front of a computer and when the game started the webcam captures the participant movements and a representation of the players appears on the computer screen as an avatar. The game goals are to intercept all falling spheres using upper limb wave movements in the exact moment the spheres reached their specific target in the bottom of computer screen. The game presented four columns with fixed targets in parallel allocated in two height levels (e.g. two on the left - targets A and B; two on the right - targets C and D). The game provides hit and miss feedback - if the individual reaches the spheres correctly, the game presented a feedback with the spheres changing the color for green (hit information). On the other hand, if the participant do not touch the spheres properly, the spheres changing the color for red and the letter X appears inside the target (miss information).
Software score During the game match (each game match lasts for 5 minutes) the participant can follow the score determined by the number of spheres hit (i.e. the information from each sphere hit appears in the bottom left side of the screen all the time) and at the end of each game match the participant had feedback with their total score (when the game match finished a total score appears in the middle of the computer screen). The game features 10 different and progressive phases of difficulty, considering the number of balls falling. In this study, all participants will start at the easiest phase (phase 1) and according to their own score, the researcher should move forward to a more difficult phase. The progression in the phase was established by the table below. Thus, each participant presents an individual progression, considering their performance.
Assessments
To characterize the participants it will be used some scales that characterize each disease and can be applied such as Pediatric Evaluation of Disability Inventory (PEDI) for children and Quality of Life and specific scales for adults. As well as sociodemographic Information: some questions will be asked, such as age, sex, income to understand the studied population.
To analyse the outcome Measures will be used: 1) Brunel Mood Scale (BRUMS) measures six identifiable affective states (Tension, Depression, Anger, Vigor, Fatigue, and Confusion) through a 24-item self-report inventory, with respondents rating a list of adjectives on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely), based on subjective feelings. The instructions refer to how participants have been feeling in the past week, including today. 2) BORG scale: is Rating of Perceived Exertion used to measure the subjective intensity of effort. It is based on the sensations felt during exercise, such as muscle fatigue, increased heart rate and increased breathing. 3) System Usability Scale (SUS), was proposed by John Brooke in 1986 as the usability test tool. It is a simple scale based on a questionnaire and has been widely adopted in product usability evaluations. The statements cover a variety of aspects of system usability such as the need for support, training, and complexity, and thus have a high level of face validity for measuring usability of a system. The SUS instrument is generally used after the respondent has had an opportunity to use the system being evaluated. This instrument is a highly robust and versatile tool for usability professionals.
1.5 Procedure and Design
Contact and assessment scales
The parent's individuals (for children) or the individual itself will be contacted by phone and asked to perform the task at home, they will be assisted by the researcher over the phone, with a video call. Important to emphasized that all participants that need assistance, will be assisted by their parents or their caregivers. First, they wiil receive a link with research information and the assent and consent form to fill out and the inclusion criteria will be checked by researcher. When they agree to participate, a link to access a questioner will be sent with Brunel Mood Scale, BORG scale, PEDI and Sociodemographic Information. When parents and participants finish those scales the gaming platform will be accessed and the participant starts the protocol practice.
Practicing the task
Participants will perform the task individually in their own house with a family member helping and giving support during all protocol. The researcher contacts the family member and gives the following instructions using videocall (research interact with the family member and the participant during all the protocol): 1) place the computer on a table and login to the platform; 2) position the cell phone (to provide videocall) on the side of the computer to receive instructions; 3) provide a comfortable sitting position in a chair (individual should be positioned at a distance of approximately 1.5 m meters from the computer monitor) and adjusted in height according to the needs of the individual (if applicable, participants could use their own wheelchair); 4) after being seated and connected to the platform the research will explain the task verbally for all participants and ask the family member to play ones (demonstrations of how to perform the coincidence timing was given form the family member during two minutes); 5) after demonstration, the family member should grab the mobile phone (to have the opportunity to move the phone and show the participant performance to the researcher during all the protocol) and 6) thus, the therapist (by video call) instructed the participant to stay still and wait the first sphere appears on the screen. Once the first sphere appears, the individual had to move his or her hand to either touch the sphere exactly at the moment coinciding with the bottom target and the game should move on with different spheres falling in the computer screen.
Protocol
As presented before the parent and participant should answer 4 assessments (Brunel Mood Scale, BORG scale, PEDI and Demographic Information), and start to perform the first game phase (phase 1), after 5 minutes playing the game the participant will answer the Borg scale and researcher will analyze the game score (e.g. according to table 2 the participant should repeat phase one or move forward for a more difficult phase); the participant started a second practice and after 5 minutes answer the Borg scale (again- the participant should repeat last phase or move forward for a more difficult phase); the participant started a third and last practice and after 5 minutes had to answer the Borg scale and to finish the protocol the BRUMS scale and the System Usability Scale (SUS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application of tele-rehabilitation | Experimental | Behavioral: Application of tele-rehabilitationIndividuals that will perform the protocol of virtual reality intervention. |
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- agreement to participate
- clinical diagnosis of the disease
- age ranging from 7 to 80 years old
Key exclusion criteria (4 listed)
- do not understand the tasks
- motor difficulties that impede the completing of the virtual tasks
- do not have technology devices to perform the virtual task (computer) or to contact the researcher (cell phone or a second computer)
- was precluded from completing the task due to some technological failure (such as internet crash).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of tele-rehabilitationIndividuals that will perform the virtual reality intervention. | Behavioural | Application of tele-rehabilitation |
Primary outcome
Motor performance.
Time frame: 1 day
The motor performance will be measured by the virtual game "MoveHero", which gives data about accuracy, precision and directional trend of movement.
1 secondary outcome
Perceived Exertion.
Time frame: 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Derived from this study: PubMed 37695272Almeida AFS, Silva TDD, Moraes IAP, Menezes LDC, Dias ED, Araujo LV, Monteiro CBM, Dawes H, Simcsik AO, Alberissi CAO, Silva VYHD, Brunherotti MAA, Tonello MGM. Virtual reality as a telerehabilitation strategy for people with autism spectrum disorder during the COVID-19 quarantine scenario: physical activity, motor performance and enjoyment. Disabil Rehabil Assist Technol. 2024 Jul;19(5):2046-2056. doi: 10.1080/17483107.2023.2249031. Epub 2023 Sep 11.
- Derived from this study: PubMed 33633648da Silva TD, da Silva PL, Valenzuela EJ, Dias ED, Simcsik AO, de Carvalho MG, Fontes AMGG, Alberissi CAO, de Araujo LV, Brandao MVDC, Dawes H, Monteiro CBM. Serious Game Platform as a Possibility for Home-Based Telerehabilitation for Individuals With Cerebral Palsy During COVID-19 Quarantine - A Cross-Sectional Pilot Study. Front Psychol. 2021 Feb 2;12:622678. doi: 10.3389/fpsyg.2021.622678. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos BM Monteiro, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of tele-rehabilitation in people with Disability Physical, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor performance. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402034, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.