Hand Injuries and DisordersNCT03750045
Grip Movement Training for Adults With Fine Motor Limitation
A study testing Jamar, Wooden box and Virtual environment in people with Hand Injuries and Disorders, run by University of Mogi das Cruzes at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries and Disorders
- What is being tested?
- Jamar, Wooden box and Virtual environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2016to 12 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not accepting to participate in this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Injuries and Disorders
- Being tested
- Jamar, Wooden box, Virtual environment
- Medical subject headings
- Hand Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Virtual environmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Jamar; Diagnostic Test: Wooden box; Other: Virtual environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes
Secondary outcomes (2)
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.
Measured: Immediately after at the Session 1, 4 and 8.
Dynamometer JAMAR
The grip strength (kgf) was evaluated in the first, fourth and eighth sessions.
Measured: Immediately after at the Session 1, 4 and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Aug 2016
- Primary completion15 Aug 2016
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terigi Augusto Scardovelli, University of Mogi das Cruzes
- Investigators
- Terigi A Scardovelli, Ph.D, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750045
- Sponsor's protocol ID
- CAAE: 56355416.3.0000.5497
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Grip Movement Training for Adults With Fine Motor Limitation
- ClinicalTrials.gov ID
- NCT03750045
- Acronym / sponsor ID
- CAAE: 56355416.3.0000.5497
- Conditions
- Hand Injuries and Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: Jamar, Diagnostic Test: Wooden box, Other: Virtual environmentFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Not accepting to participate in this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JamarThe 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 | Experimental group |
| Wooden boxThe 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. | Diagnostic test | Experimental group |
| Virtual environmentThe 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. | Other | Experimental group |
Primary outcome
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.
2 secondary outcomes
Wooden box
Time frame: Immediately after at the Session 1, 4 and 8.
Dynamometer JAMAR
Time frame: Immediately after at the Session 1, 4 and 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terigi A Scardovelli, Ph.D principal investigator
University of Mogi das Cruzes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jamar, Wooden box and Virtual environment in people with Hand Injuries and Disorders, run by University of Mogi das Cruzes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual environment (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.