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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03750045
Other study ID # CAAE: 56355416.3.0000.5497
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date April 12, 2017

Study information

Verified date November 2018
Source University of Mogi das Cruzes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In order to elaborate the virtual environment, softwares for 3D content creation were used. The virtual environment is formed by four phases, each one having three spheres that are supposed to be inserted, one by one, into a hole located on the scenario floor. Each phase presents a level of difficulty, from pushing the object to performing the grip movement. By the end of each phase, a log file is generated with the time spent on it.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date April 12, 2017
Est. primary completion date August 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- Not accepting to participate in this research

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Jamar
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.
Wooden box
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.
Other:
Virtual environment
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.

Locations

Country Name City State
Brazil Terigi Augusto Scardovelli Mogi das Cruzes São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Mogi das Cruzes

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Wooden box The motor coordination evaluation was made in the first, fourth and eighth sessions. Each volunteer used three balls, or spheres, of different sizes (small, medium, large). The objective was to insert each ball in each orifice. The time was measured with a chronometer. Immediately after at the Session 1, 4 and 8.
Secondary Dynamometer JAMAR The grip strength (kgf) was evaluated in the first, fourth and eighth sessions. Immediately after at the Session 1, 4 and 8.
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