- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03750045
Grip Movement Training for Adults With Fine Motor Limitation
November 20, 2018 updated by: Terigi Augusto Scardovelli, University of Mogi das Cruzes
Proposal for Grip Movement Training for Adults With Fine Motor Limitation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Mogi das Cruzes, São Paulo, Brazil, 08780-911
- Terigi Augusto Scardovelli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virtual environment
Time Frame: 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.
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wooden box
Time Frame: 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.
|
Immediately after at the Session 1, 4 and 8.
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Dynamometer JAMAR
Time Frame: Immediately after at the Session 1, 4 and 8.
|
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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Terigi A Scardovelli, Ph.D, University of Mogi das Cruzes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
August 15, 2016
Study Completion (Actual)
April 12, 2017
Study Registration Dates
First Submitted
November 19, 2018
First Submitted That Met QC Criteria
November 20, 2018
First Posted (Actual)
November 21, 2018
Study Record Updates
Last Update Posted (Actual)
November 21, 2018
Last Update Submitted That Met QC Criteria
November 20, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 56355416.3.0000.5497
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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