Grip Movement Training for Adults With Fine Motor Limitation

Sponsor

University of Mogi das Cruzes (Other)

Overall Status

Completed

CT.gov ID

NCT03750045

Collaborator

(none)

Enrollment

Location

Arm

8.3

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Injuries and Disorders	Diagnostic Test: Jamar Diagnostic Test: Wooden box Other: Virtual environment	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Proposal for Grip Movement Training for Adults With Fine Motor Limitation

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Aug 15, 2016

Actual Study Completion Date :

Apr 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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: 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. Diagnostic Test: 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.

Arm

Intervention/Treatment

Experimental: Experimental group

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: 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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

Virtual environment [120 minutes]
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.

Secondary Outcome Measures

Wooden box [Immediately after at the Session 1, 4 and 8.]
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.
Dynamometer JAMAR [Immediately after at the Session 1, 4 and 8.]
The grip strength (kgf) was evaluated in the first, fourth and eighth sessions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Terigi Augusto Scardovelli	Mogi das Cruzes	São Paulo	Brazil	08780-911

Sponsors and Collaborators

University of Mogi das Cruzes

Investigators

Principal Investigator: Terigi A Scardovelli, Ph.D, University of Mogi das Cruzes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Terigi Augusto Scardovelli, Principal Investigator, University of Mogi das Cruzes

ClinicalTrials.gov Identifier:

NCT03750045

Other Study ID Numbers:

CAAE: 56355416.3.0000.5497

First Posted:

Nov 21, 2018

Last Update Posted:

Nov 21, 2018

Last Verified:

Nov 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hand Injuries

Study Results

No Results Posted as of Nov 21, 2018