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Completed

NCT Number: NCT02877030

Sensorimotor Exercises in Virtual Reality Platform 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

Completed

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Católica do Salvador

Salvador, Estado de Bahia, 40000-00, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

video game

Other

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.

Primary outcomes

  1. Timed up and Go

    Time frame: average 8 weeks

    Functional mobility in patients with HTLV-1 undergoing rehabilitation with video game

  2. 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

  3. 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 outcomes

  1. Brief Pain Inventory (BPI)

    Time frame: average 8 weeks

    Pain in patients with HTLV-1 undergoing rehabilitation with video game

  2. WHOQOL BRIEF

    Time frame: average 8 weeks

    Quality of life in patients with HTLV-1 undergoing rehabilitation with video game

Sponsors and collaborators

Lead sponsor

Pedreira, Érika, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 24, 2016
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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