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

September 24, 2014 updated by: Niels Kildebro, Herlev Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Baseline
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
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.
Device: Star shaped manual dexterity test
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.
Active Comparator: Fatigue
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
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.
Device: Star shaped manual dexterity test
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.
Active Comparator: Stress
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.
Device: Star shaped manual dexterity test
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.
Other: Stress
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
Active Comparator: Fatigue and Stress
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
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.
Device: Star shaped manual dexterity test
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.
Other: Stress
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Completion time of the star shaped manual dexterity test.
Time Frame: up to day 10
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of errors during the completion of the star shaped manual dexterity test.
Time Frame: Test completion period at day 1, 4, 7 and 10
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niels Kildebro, BSc.med., Herlev Hospital, Copenhagen University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STAR-222

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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