Clinical trial NCT02877030: Sensorimotor Exercises in Virtual Reality Platform in Individuals With Human T-lymphotropic Virus
Official title: Sensorimotor Exercises in Virtual Reality Platform and Balance in Individuals With Human T-lymphotropic Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HTLV-1
Lead sponsor: Pedreira, Érika, M.D.
Sponsor class: INDIV
First posted: 2016-08-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* people having a previous diagnosis of HTLV-1, which can remain in standing position without assistance.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Timed up and Go
timeFrame: average 8 weeks
measure: Gait performance at CvMob (Software for movement analysis)
timeFrame: an average 8 weeks
measure: Posture analysis at CvMob (Software for movement analysis)
timeFrame: average 8 weeks
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: average 8 weeks
measure: WHOQOL BRIEF
timeFrame: average 8 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Universidade Católica do Salvador
state: Bahia
Study officials:
affiliation: Pedreira, Érika, M.D.
name: Erika Fonseca, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.