Validation and Test-retest Study of the Star-shaped Manual Dexterity Test.

Study Overview
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Brief Summary
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The purpose of this study is to measure test-retest reliability and validate the star shaped test of manual dexterity. The purpose of this is to see if there is any significant learning effect, and if the test can discriminate between individuals who are at their normal skill level, and when they are stressed and/or fatigued. The test is designed to test hand to eye coordination and precision control. This is done by following a star shaped track with a pair of a surgical scissors. this is done 10 times, 5 times clockwise and 5 times counter clockwise. Each time the scissors come into contact with the border of the track, an error is counted. Overall completion time is recorded. As a randomized crossover study, we will have 20 test subjects complete the test 4 times. Each test will be conducted with a pause of two breaks between the tests. Before each test, the test subjects are randomized to: no intervention, physical fatigue prior to testing, distractions during the test or both physical fatigue prior to testing and distractions during the test. All participants will complete a test with all four interventions. Furthermore, a test-retest trial will be conducted on 4 test-subjects. Each subject will complete the test two times with no interventions, with two days apart.

Conditions
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Manual Dexterity

Intervention / Treatment
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* Other: Stretched arm test
* Other: Stress
* Device: Star shaped manual dexterity test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 55 years Exclusion Criteria: Diagnosed heart disease Diagnosed endocrinological disease Diagnosed Neurological or autoimmune disease Diagnosed Sleep disorder Diagnosed orthopedic diseases or former orthopedic surgery (e.g. arthrosis, rotator cuff syndrome)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baseline<br>Completion of the star shaped manual dexterity test, five rounds clockwise and five rounds counter clockwise without any intervention. Time and number of errors are recorded. Measurement of static arm strength with the stretched arm test. test subject is asked to hold a 2.5 kg weight in stretched arm for as long as possible. Maximum endurance time is recorded. | Other: Stretched arm test<br>* Measurement of static arm strength. Test subject is asked to hold a 2.5 kg weight in their dominant arm fully extended at 90-degree flexion and 15-degree abduction as long as possible without moving.<br>Device: Star shaped manual dexterity test<br>* On a piece of wood, a piece of metal (dimensions 22 cm x 22 cm) is mounted. In the center of the metal plate, is a star shaped track. The star has 6 points and the track is 9 mm wide. It measures 15,3 cm from the tips of opposing arms of the star. With a surgical scissor in his dominant hand, the test subject is instructed to follow the star shaped track ten times, five times clockwise and five times counter clockwise. Contact with the border of the track is counted as an error. A computer software program automatically registers completion time and number of errors. The test is conducted in an undisturbed environment.<br>|
| Active Comparator: Fatigue<br>Prior to completion of the star shaped manual dexterity test, the test subject is asked to stand up still and hold a 2.5-kg weight with the dominant arm fully extended as long as possible without moving. Maximum endurance time is recorded. After this, the test subject completes the the star shaped manual dexterity test and time and number of errors are recorded. | Other: Stretched arm test<br>* Measurement of static arm strength. Test subject is asked to hold a 2.5 kg weight in their dominant arm fully extended at 90-degree flexion and 15-degree abduction as long as possible without moving.<br>Device: Star shaped manual dexterity test<br>* On a piece of wood, a piece of metal (dimensions 22 cm x 22 cm) is mounted. In the center of the metal plate, is a star shaped track. The star has 6 points and the track is 9 mm wide. It measures 15,3 cm from the tips of opposing arms of the star. With a surgical scissor in his dominant hand, the test subject is instructed to follow the star shaped track ten times, five times clockwise and five times counter clockwise. Contact with the border of the track is counted as an error. A computer software program automatically registers completion time and number of errors. The test is conducted in an undisturbed environment.<br>|
| Active Comparator: Stress<br>During completion of the star shaped manual dexterity test, the test subject is asked to identify cards from a regular deck of playing card by naming the suit and rank of the card. They will be asked to identify one random card during each of the 10 rounds in the completion of the test. Completion time and number of errors are recorded. | Other: Stress<br>* During completion of the star shaped manual dexterity test, the test subject is asked to identify cards from a regular deck of playing card by naming the suit and rank of the card. They will be asked to identify one random card during each of the 10 rounds in the completion of the test<br>Device: Star shaped manual dexterity test<br>* On a piece of wood, a piece of metal (dimensions 22 cm x 22 cm) is mounted. In the center of the metal plate, is a star shaped track. The star has 6 points and the track is 9 mm wide. It measures 15,3 cm from the tips of opposing arms of the star. With a surgical scissor in his dominant hand, the test subject is instructed to follow the star shaped track ten times, five times clockwise and five times counter clockwise. Contact with the border of the track is counted as an error. A computer software program automatically registers completion time and number of errors. The test is conducted in an undisturbed environment.<br>|
| Active Comparator: Fatigue and Stress<br>The test subject will be fatigued prior to the test (as detailed in the fatigue arm), and asked to identify cards during completion of the star shaped manual dexterity test (as detailed in the stress arm). Completion time and number of errors are recorded. | Other: Stretched arm test<br>* Measurement of static arm strength. Test subject is asked to hold a 2.5 kg weight in their dominant arm fully extended at 90-degree flexion and 15-degree abduction as long as possible without moving.<br>Other: Stress<br>* During completion of the star shaped manual dexterity test, the test subject is asked to identify cards from a regular deck of playing card by naming the suit and rank of the card. They will be asked to identify one random card during each of the 10 rounds in the completion of the test<br>Device: Star shaped manual dexterity test<br>* On a piece of wood, a piece of metal (dimensions 22 cm x 22 cm) is mounted. In the center of the metal plate, is a star shaped track. The star has 6 points and the track is 9 mm wide. It measures 15,3 cm from the tips of opposing arms of the star. With a surgical scissor in his dominant hand, the test subject is instructed to follow the star shaped track ten times, five times clockwise and five times counter clockwise. Contact with the border of the track is counted as an error. A computer software program automatically registers completion time and number of errors. The test is conducted in an undisturbed environment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion time of the star shaped manual dexterity test. | The time in seconds it takes to complete 10 rounds of the star shaped manual dexterity test. First 5 rounds clockwise and then 5 rounds counter clockwise. The test will be performed on day 1, 4, 7 and 10 of the study. | up to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of errors during the completion of the star shaped manual dexterity test. | An error is counted each time the test subject touches the borders of the star shaped track of the manual dexterity test with the surgical scissor. | Test completion period at day 1, 4, 7 and 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual dexterity, hand to eye coordination, stress, fatigue