- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04174729
System for Quantifying the Functional Strength of the Grip and Pinch Movements
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Mogi das Cruzes, São Paulo, Brazil, 08780-911
- Silvia Regina Matos da Silva Boschi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- only right-handed individuals,
- male and female,
- have preserved cognitive functions,
- absence of neurological disorder
- who present minimum grip strength by the Jamar ® dynamometer, in the age group of 20-29 years men 45.08 ± 0.67 kg and women of 27.2 ± 0.46 kg, who present minimum grip strength by the dynamometer Jamar ®, aged 30 to 39 years old men 46.05 ± 0.47 kg and women 28.0 ± 0.39 kg, using the mean minus the standard deviation.
Exclusion Criteria:
- Injury to upper limbs such as amputation, recent surgery (6 months), fractures, bruising, pain and musculoskeletal disorders.
- Do not accept to participate in the survey.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hand strength
The tests were performed in two sessions lasting 1 hour each. The volunteers used the devices: door handle, tap, door pull handle, switch and door key to quantify hand strength. The tests were performed in two sessions lasting 1 hour each. The volunteers used the devices: door handle, tap, door pull handle, switch and door key to quantify hand strength. In the first session, the volunteers performed the movements 3 times in each device of daily living activities with the right limb, with a 1-minute rest interval between the 3 measurements. The entire procedure performed in the session was repeated again after 30 minutes to verify the reliability and reproducibility of the Intra-evaluator test. The Inter-rater test was repeated after 7 days by the second rater to analyze reliability between the rater. |
First, the hand measurements of each volunteer were evaluated, followed by the measurement of handgrip strength using the Jamar® dynamometer.
And later the tests were performed using the system that contains the 5 devices to quantify the hand strength.
Other Names:
To evaluate the cylindrical grip movement, a door handle was used, which evaluated the full force in the range of motion.
To evaluate the spherical grip movement, a tap was used, which evaluated the full force in the range of motion.
To assess the hook grip movement, a door pull handle was used, which assessed the full force in the range of motion
To evaluate the pulp-pulp pinch movement, a switch was used, which evaluated the full force in the movement of the movement.
To assess the pulp-side pinch movement, a door key was used, which evaluated the full force in the range of motion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength device
Time Frame: 15 minutes
|
The strength of the cylindrical grip movement was quantified through the door handle device, the spherical grip strength through the tap device, the hook grip strength through the vertical door pull handle, the pulp-pulp pinch strength through the linear switch device and the pulp-side pinch strength through the key device. The test was quantified 3 times with a 1 minute interval between each test and the force throughout the range of motion. Unit of measure: newton (N). |
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion in angle
Time Frame: 15 minutes
|
The test measured the range of motion of the door handle device, the tap device, door pull handle device and the door key device, 3 times with 1 minute interval for each test, in which all range of motion was measured from its start until its end.
Unit of measure: Angle (º).
|
15 minutes
|
|
Range of motion millimeter
Time Frame: 15 minutes
|
The test measured the range of motion in a linear switch device 3 times with a 1 minute interval for each test, in which all of the range of motion was measured from its start until its end.
Unit measurement: millimeter (mm).
|
15 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric variables
Time Frame: 5 minutes
|
The anthropometric measurement of the right hand was performed using an analog caliper, as it is an important parameter for functional evaluation, as it was of the following anatomical parts: total length of the hand (wrist crease to middle finger tip), longitudinal length of the palm from the hand (wrist crease to the proximal crease of the middle finger) and transverse length of the palm (lateral to medial line of the metacarpophalangeal muscles).
Unit of measure: millimeter (mm)
|
5 minutes
|
|
Dynamometer Jamar Strength
Time Frame: 1 minute
|
To make the sample more homogeneous, the Jamar ® dynamometer was used to measure grip strength maximum contraction for 3 seconds.
A single measurement was performed.
Unit of measure: kilogram - force (kgf).
|
1 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Silvia R Boschi, PhD, University of Mogi das Cruzes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19020219.2.0000.5497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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