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

HTLV-1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877030
• Other study ID #: PedreiraE
• Status: Completed
• Phase: N/A
• Start date: April 2, 2017
• Est. completion date: May 5, 2018

Study information

• Verified date: May 2018
• Source: Pedreira, Érika, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 5, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HTLV-1

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade Católica do Salvador	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Pedreira, Érika, M.D.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up and Go	Functional mobility in patients with HTLV-1 undergoing rehabilitation with video game	average 8 weeks
Primary	Gait performance at CvMob (Software for movement analysis)	Gait performance in patients with HTLV-1 undergoing rehabilitation with video game	an average 8 weeks
Primary	Posture analysis at CvMob (Software for movement analysis)	Posture analysis in patients with HTLV-1 undergoing rehabilitation with video game	average 8 weeks
Secondary	Brief Pain Inventory (BPI)	Pain in patients with HTLV-1 undergoing rehabilitation with video game	average 8 weeks
Secondary	WHOQOL BRIEF	Quality of life in patients with HTLV-1 undergoing rehabilitation with video game	average 8 weeks