NCT04402034

Brief Summary

This is a cross-sectional study, that is going to be conducted during the quarantine, period established by the state of São Paulo to reduce the transmission of COVID-19, between March 24 2020 and May 31 2020. Thus, the differential of this study is to use 100% telerehabilitation, in which the rehabilitation team and participants only had telephone contact, communication application (WhatsApp) and software interaction. 40 participants will be included. Potential and interested volunteers will be assessed by a detailed screening using the eligibility criteria and attended an initial selection for enrolment in the study. It wiil be used a platform called MoveHero, available for free use in https://movehero.com.br/. The individual needs access the internet, and once he gets online, he had to create his own account, inserting his name, email and creating a password. Considering that the platform presents different levels of difficulty, after the participant is connected to the platform, the researcher directed the participant to the protocol bespoke for each participant, playing 3 rounds of the game for 5 minutes each (total of 15 minutes). During the intervention, it will be applied BORG scale in order to assess their perceived effort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

May 20, 2020

Last Update Submit

October 22, 2020

Conditions

Keywords

Disability Physical

Outcome Measures

Primary Outcomes (1)

  • Motor performance.

    The motor performance will be measured by the virtual game "MoveHero", which gives data about accuracy, precision and directional trend of movement.

    1 day

Secondary Outcomes (1)

  • Perceived Exertion.

    1 day.

Study Arms (1)

Application of tele-rehabilitation

EXPERIMENTAL

Individuals that will perform the protocol of virtual reality intervention.

Behavioral: Application of tele-rehabilitation

Interventions

Individuals that will perform the virtual reality intervention.

Application of tele-rehabilitation

Eligibility Criteria

Age7 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • agreement to participate
  • clinical diagnosis of the disease
  • age ranging from 7 to 80 years old

You may not qualify if:

  • do not understand the tasks
  • motor difficulties that impede the completing of the virtual tasks
  • do not have technology devices to perform the virtual task (computer) or to contact the researcher (cell phone or a second computer)
  • was precluded from completing the task due to some technological failure (such as internet crash).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

São Paulo, 03828-000, Brazil

Location

Related Publications (1)

  • da Silva TD, da Silva PL, Valenzuela EJ, Dias ED, Simcsik AO, de Carvalho MG, Fontes AMGG, Alberissi CAO, de Araujo LV, Brandao MVDC, Dawes H, Monteiro CBM. Serious Game Platform as a Possibility for Home-Based Telerehabilitation for Individuals With Cerebral Palsy During COVID-19 Quarantine - A Cross-Sectional Pilot Study. Front Psychol. 2021 Feb 2;12:622678. doi: 10.3389/fpsyg.2021.622678. eCollection 2021.

Study Officials

  • Carlos BM Monteiro, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 26, 2020

Study Start

May 15, 2020

Primary Completion

October 20, 2020

Study Completion

October 21, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations