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

Overview

Testing the effectiveness of an exercise protocol engines sensory performed through a virtual reality platform in individuals infected with HTLV-1

Full Title of Study: “Sensorimotor Exercises in Virtual Reality Platform and Balance in Individuals With Human T-lymphotropic Virus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 20, 2017

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Test control group
    • Start the sensorimotor exercises protocol with video game immediately after the first evaluation
  • Active Comparator: Control test group
    • Start of sensorimotor exercises with video game protocol after ten weeks
  • No Intervention: comparison group
    • No intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pedreira, Érika, M.D.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Érika Pedreira, M.D. – Pedreira, Érika, M.D.
  • Overall Official(s)
    • Erika Fonseca, M.D., Principal Investigator, Pedreira, Érika, M.D.

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