Sensorimotor Exercises in Virtual Reality Platform in Individuals With Human T-lymphotropic Virus

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

Study Overview

• Status: Completed
• Conditions: HTLV-1
• Intervention / Treatment: Other: Video game

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40000-00
      • Universidade Católica do Salvador

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test control group; Start the sensorimotor exercises protocol with video game immediately after the first evaluation	Other: Video game; 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.
ACTIVE_COMPARATOR: Control test group; Start of sensorimotor exercises with video game protocol after ten weeks	Other: Video game; 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.
NO_INTERVENTION: comparison group; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory (BPI)	Pain in patients with HTLV-1 undergoing rehabilitation with video game	average 8 weeks
WHOQOL BRIEF	Quality of life in patients with HTLV-1 undergoing rehabilitation with video game	average 8 weeks

Collaborators and Investigators

• Sponsor: Pedreira, Érika, M.D.
• Investigators: Principal Investigator: Erika Fonseca, M.D., Pedreira, Érika, M.D.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2017
• Primary Completion (ACTUAL): December 20, 2017
• Study Completion (ACTUAL): May 5, 2018

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (ESTIMATE): August 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PedreiraE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No