Back to resultsGrip Movement Training for Adults With Fine Motor Limitation
Primary Purpose
Hand Injuries and Disorders
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Jamar
Wooden box
Virtual environment
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injuries and Disorders
Eligibility Criteria
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
Sites / Locations
- Terigi Augusto Scardovelli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Dynamometer JAMAR
The grip strength (kgf) was evaluated in the first, fourth and eighth sessions.
Full Information
NCT ID
NCT03750045
First Posted
November 19, 2018
Last Updated
November 20, 2018
Sponsor
University of Mogi das Cruzes
1. Study Identification
Unique Protocol Identification Number
NCT03750045
Brief Title
Grip Movement Training for Adults With Fine Motor Limitation
Official Title
Proposal for Grip Movement Training for Adults With Fine Motor Limitation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 15, 2016 (Actual)
Study Completion Date
April 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mogi das Cruzes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries and Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Jamar
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Wooden box
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual environment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Virtual environment
Description
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.
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Wooden box
Description
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.
Time Frame
Immediately after at the Session 1, 4 and 8.
Title
Dynamometer JAMAR
Description
The grip strength (kgf) was evaluated in the first, fourth and eighth sessions.
Time Frame
Immediately after at the Session 1, 4 and 8.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terigi A Scardovelli, Ph.D
Organizational Affiliation
University of Mogi das Cruzes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Terigi Augusto Scardovelli
City
Mogi das Cruzes
State/Province
São Paulo
ZIP/Postal Code
08780-911
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Grip Movement Training for Adults With Fine Motor Limitation
We'll reach out to this number within 24 hrs