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

NCT ID: NCT02877030

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-02

Study Completion Date

2018-05-05

Brief Summary

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

Detailed Description

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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.

Conditions

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HTLV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test control group

Start the sensorimotor exercises protocol with video game immediately after the first evaluation

Group Type EXPERIMENTAL

Video game

Intervention Type 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.

Control test group

Start of sensorimotor exercises with video game protocol after ten weeks

Group Type ACTIVE_COMPARATOR

Video game

Intervention Type 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.

comparison group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pedreira, Érika, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Érika Pedreira

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erika Fonseca, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pedreira, Érika, M.D.

Locations

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Universidade Católica do Salvador

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 32737862 (View on PubMed)

Other Identifiers

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PedreiraE

Identifier Type: -

Identifier Source: org_study_id

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