NCT03750045

Brief Summary

This study is to test the system composed by a 3D virtual environment, attached to the Leap Motion, evaluating its effects on the rehabilitation of hand movements in patients with motor alteration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

14 days

First QC Date

November 19, 2018

Last Update Submit

November 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Virtual environment

    The intervention was composed by 8 sessions of 15 minutes each, where the volunteers used a virtual environment attached it to a Leap Motion, which is a sensor that allows to capture the movements that are produced by the hands and reproduce them in a computer through a 3D virtual environment in order to stimulate the execution of their finer movements.

    120 minutes

Secondary Outcomes (2)

  • Wooden box

    Immediately after at the Session 1, 4 and 8.

  • Dynamometer JAMAR

    Immediately after at the Session 1, 4 and 8.

Study Arms (1)

Experimental group

EXPERIMENTAL

For the tests, the volunteers used the access device (Leap Motion) and a computer that were previously installed. The intervention was composed by 8 sessions of 15 minutes each, where the volunteers used a virtual environment attached it to a Leap Motion, which is a sensor that allows to capture the movements that are produced by the hands and reproduce them in a computer through a 3D virtual environment in order to stimulate the execution of their finer movements. The strength (Jamar) and motor coordination (wooden box) evaluations were made in the first, fourth and eighth sessions with the objective of checking the gain progression or not of motion coordination and grip strength.

Diagnostic Test: JamarDiagnostic Test: Wooden boxOther: Virtual environment

Interventions

JamarDIAGNOSTIC_TEST

The grip strength was evaluated through a dynamometer JAMAR 5030-J, formed by two parallel steel bars, one stationary and a mobile one, which can be adjusted in five different positions. The volunteer was sitting with a neutrally rotated abducted shoulder, elbow flexed at 90°, the forearm in neutral position, and the wrist between 0° and 30° of extension, 0° to 15° of ulnar variance and it was requested that he or she made the grip movement. This test was performed three times with a one-minute-break between each one.

Experimental group
Wooden boxDIAGNOSTIC_TEST

The motor coordination evaluation was made through the measurement of the time spent to perform the task of fitting. To do so, a wooden box was built. In its upper part, there is a circular orifice with 6 cm of diameter.

Experimental group

The system proposed is composed by a virtual environment and an access device. The Leap Motion was used as the access device, making it possible to capture the movements performed by the hands.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women with age equal or higher than 18 years old;
  • having clinical diagnosis of neurological pathology;
  • presenting fine motor coordination deficit and in grip strength;
  • being able to understand instructions in order to perform the tasks of the virtual environment;
  • minimum score of 23/24 (from a total of 30) in the Mini-Mental State Examination (MMSE)

You may not qualify if:

  • Not accepting to participate in this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Terigi Augusto Scardovelli

Mogi das Cruzes, São Paulo, 08780-911, Brazil

Location

MeSH Terms

Conditions

Hand InjuriesDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Terigi A Scardovelli, Ph.D

    University of Mogi das Cruzes

    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
Principal Investigator

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 21, 2018

Study Start

August 1, 2016

Primary Completion

August 15, 2016

Study Completion

April 12, 2017

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations