HTLV-1NCT02877030
Sensorimotor Exercises in Virtual Reality Platform in Individuals With Human T-lymphotropic Virus
A study testing Video game in people with HTLV-1, run by Pedreira, Érika, M.D. at 1 site in Brazil.
Trial summary
Testing the effectiveness of an exercise protocol engines sensory performed through a virtual reality platform in individuals infected with HTLV-1 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HTLV-1
- What is being tested?
- Video game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2017to 5 May 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- people having a previous diagnosis of HTLV-1, which can remain in standing position without assistance.
Who cannot join
- amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Católica do Salvador
Salvador, Estado de Bahia, 40000-00
About this study
Official title: Sensorimotor Exercises in Virtual Reality Platform and Balance in Individuals With Human T-lymphotropic Virus
Testing the effectiveness of an exercise protocol engines sensory performed through a virtual reality platform in individuals infected with HTLV-1
Read the detailed description
Crossover randomized clinical trial to be conducted with people having a previous diagnosis of HTLV-1, they can remain in standing position without assistance. They will be excluded from those presenting amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used. They will also be recruited to a comparative group, healthy individuals, matched for sex, age and education level. It will be performed three assessments, before randomization, after 10 weeks and after 20 weeks, which will be evaluated in balance, functional mobility, gait and posture. The participants infected with HTLV-1, will be divided into two groups by random distribution, a group will begin the treatment protocol with video game immediately after the first evaluation and the other after ten weeks, with the crossing of the groups . Concealment of allocation will be guaranteed to the examiners who will have no contact with the physiotherapist who will apply the exercise protocol and the team member responsible for drawing. Patients will also be instructed to maintain confidentiality of the entry in the exercise program to other patients and examiners.
- Conditions
- HTLV-1
- Being tested
- Video game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video gameOther
The protocol sensorimotor exercises consist of a virtual game that attaches to the Nintendo Wii and using arrows that are thrown from above, players must perform weight-shifting movements in the Nintendo platform to the target be directed to the trajectory the arrows. The goal is to catch as many arrows.
| Study group | Role | What they receive |
|---|---|---|
| Test control group | Experimental | Start the sensorimotor exercises protocol with video game immediately after the first evaluation Receives: Other: Video game |
| Control test group | Active comparator | Start of sensorimotor exercises with video game protocol after ten weeks Receives: Other: Video game |
| comparison group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and Go
Functional mobility in patients with HTLV-1 undergoing rehabilitation with video game
Measured: average 8 weeks
Gait performance at CvMob (Software for movement analysis)
Gait performance in patients with HTLV-1 undergoing rehabilitation with video game
Measured: an average 8 weeks
Posture analysis at CvMob (Software for movement analysis)
Posture analysis in patients with HTLV-1 undergoing rehabilitation with video game
Measured: average 8 weeks
Secondary outcomes (2)
Brief Pain Inventory (BPI)
Pain in patients with HTLV-1 undergoing rehabilitation with video game
Measured: average 8 weeks
WHOQOL BRIEF
Quality of life in patients with HTLV-1 undergoing rehabilitation with video game
Measured: average 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start2 Apr 2017
- Primary completion20 Dec 2017
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HTLV-1Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedreira, Érika, M.D.
- Responsible party
- Principal investigator, Érika Pedreira, Pedreira, Érika, M.D.
- Investigators
- Erika Fonseca, M.D., Principal investigator, Pedreira, Érika, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877030
- Sponsor's protocol ID
- PedreiraE
- Status last verified
- May 2018
- First submitted
- 11 Aug 2016
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patricio NA, Vidal DG, Pinto EB, Sa KN, Baptista AF. Effectiveness of virtual reality games for falls, postural oscillations, pain and quality of life of individual HAM/TSP: a randomized, controlled, clinical trial. J Neurovirol. 2020 Oct;26(5):676-686. doi: 10.1007/s13365-020-00880-x. Epub 2020 Jul 31.
PubMed 32737862
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Exercises in Virtual Reality Platform and Balance in Individuals With Human T-lymphotropic Virus
- ClinicalTrials.gov ID
- NCT02877030
- Acronym / sponsor ID
- PedreiraE
- Conditions
- HTLV-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pedreira, Érika, M.D.
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 24 Aug 2016 (estimated)
- 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.
Testing the effectiveness of an exercise protocol engines sensory performed through a virtual reality platform in individuals infected with HTLV-1
Detailed description
Crossover randomized clinical trial to be conducted with people having a previous diagnosis of HTLV-1, they can remain in standing position without assistance. They will be excluded from those presenting amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used. They will also be recruited to a comparative group, healthy individuals, matched for sex, age and education level. It will be performed three assessments, before randomization, after 10 weeks and after 20 weeks, which will be evaluated in balance, functional mobility, gait and posture. The participants infected with HTLV-1, will be divided into two groups by random distribution, a group will begin the treatment protocol with video game immediately after the first evaluation and the other after ten weeks, with the crossing of the groups . Concealment of allocation will be guaranteed to the examiners who will have no contact with the physiotherapist who will apply the exercise protocol and the team member responsible for drawing. Patients will also be instructed to maintain confidentiality of the entry in the exercise program to other patients and examiners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test control group | Experimental | Other: Video gameStart the sensorimotor exercises protocol with video game immediately after the first evaluation |
| Control test group | Active comparator | Other: Video gameStart of sensorimotor exercises with video game protocol after ten weeks |
| comparison group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- people having a previous diagnosis of HTLV-1, which can remain in standing position without assistance.
Key exclusion criteria (1 listed)
- amputation of the lower limbs, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other neurological disorders associated and those that are experiencing difficulty in understanding the assessment tools used.
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 |
|---|---|---|
| Video gameThe protocol sensorimotor exercises consist of a virtual game that attaches to the Nintendo Wii and using arrows that are thrown from above, players must perform weight-shifting movements in the Nintendo platform to the target be directed to the trajectory the arrows. The goal is to catch as many arrows. | Other | Control test group, Test control group |
Primary outcome
Timed up and Go
Time frame: average 8 weeks
Functional mobility in patients with HTLV-1 undergoing rehabilitation with video game
Gait performance at CvMob (Software for movement analysis)
Time frame: an average 8 weeks
Gait performance in patients with HTLV-1 undergoing rehabilitation with video game
Posture analysis at CvMob (Software for movement analysis)
Time frame: average 8 weeks
Posture analysis in patients with HTLV-1 undergoing rehabilitation with video game
2 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: average 8 weeks
WHOQOL BRIEF
Time frame: average 8 weeks
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 6 Jun 2019.
- Derived from this study: PubMed 32737862Patricio NA, Vidal DG, Pinto EB, Sa KN, Baptista AF. Effectiveness of virtual reality games for falls, postural oscillations, pain and quality of life of individual HAM/TSP: a randomized, controlled, clinical trial. J Neurovirol. 2020 Oct;26(5):676-686. doi: 10.1007/s13365-020-00880-x. Epub 2020 Jul 31.
- 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.
Erika Fonseca, M.D. principal investigator
Pedreira, Érika, M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game in people with HTLV-1, run by Pedreira, Érika, M.D. 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 1 inclusion and 1 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 6 Jun 2019. 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?
Timed up and Go (time frame: average 8 weeks). The study lists 3 primary outcomes in all. 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 NCT02877030, which also lists 1 linked publication.
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 6 Jun 2019.