Sensorimotor Exercises in Virtual Reality Platform in Individuals With Human T-lymphotropic Virus
1 other identifier
interventional
42
1 country
1
Brief Summary
Testing the effectiveness of an exercise protocol engines sensory performed through a virtual reality platform in individuals infected with HTLV-1
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedStudy Start
First participant enrolled
April 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2018
CompletedJune 6, 2019
May 1, 2018
9 months
August 11, 2016
June 4, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Timed up and Go
Functional mobility in patients with HTLV-1 undergoing rehabilitation with video game
average 8 weeks
Gait performance at CvMob (Software for movement analysis)
Gait performance in patients with HTLV-1 undergoing rehabilitation with video game
an average 8 weeks
Posture analysis at CvMob (Software for movement analysis)
Posture analysis in patients with HTLV-1 undergoing rehabilitation with video game
average 8 weeks
Secondary Outcomes (2)
Brief Pain Inventory (BPI)
average 8 weeks
WHOQOL BRIEF
average 8 weeks
Study Arms (3)
Test control group
EXPERIMENTALStart the sensorimotor exercises protocol with video game immediately after the first evaluation
Control test group
ACTIVE COMPARATORStart of sensorimotor exercises with video game protocol after ten weeks
comparison group
NO INTERVENTIONNo intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- people having a previous diagnosis of HTLV-1, which can remain in standing position without assistance.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Católica do Salvador
Salvador, Estado de Bahia, 40000-00, Brazil
Related Publications (1)
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.
PMID: 32737862DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Erika Fonseca, M.D.
Pedreira, Érika, M.D.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 11, 2016
First Posted
August 24, 2016
Study Start
April 2, 2017
Primary Completion
December 20, 2017
Study Completion
May 5, 2018
Last Updated
June 6, 2019
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share