Manual DexterityNCT02146443
Validation and Test-retest Study of the Star-shaped Manual Dexterity Test.
A study testing Stretched arm test, Stress and Star shaped manual dexterity test in people with Manual Dexterity, run by Herlev Hospital at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Dexterity
- What is being tested?
- Stretched arm test, Stress and Star shaped manual dexterity test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Sep 2014
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 55 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Manual Dexterity
- Being tested
- Stretched arm test, Stress, Star shaped manual dexterity test
- Keywords
- Manual dexterity, hand to eye coordination, stress, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretched arm testOther
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.
StressOther
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
Star shaped manual dexterity testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Active comparator | 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. Receives: Other: Stretched arm test; Device: Star shaped manual dexterity test |
| Fatigue | Active comparator | 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. Receives: Other: Stretched arm test; Device: Star shaped manual dexterity test |
| Stress | Active comparator | 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. Receives: Other: Stress; Device: Star shaped manual dexterity test |
| Fatigue and Stress | Active comparator | 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. Receives: Other: Stretched arm test; Other: Stress; Device: Star shaped manual dexterity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to day 10
Secondary outcomes (1)
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.
Measured: Test completion period at day 1, 4, 7 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual DexterityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Kildebro, Herlev Hospital
- Investigators
- Niels Kildebro, BSc.med., Principal investigator, Herlev Hospital, Copenhagen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146443
- Sponsor's protocol ID
- STAR-222
- Status last verified
- Sep 2014
- First submitted
- 21 May 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Test-retest Study of the Star-shaped Manual Dexterity Test.
- ClinicalTrials.gov ID
- NCT02146443
- Acronym / sponsor ID
- STAR-222
- Conditions
- Manual Dexterity
- Keywords
- Manual dexterity, hand to eye coordination, stress, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 May 2014 (estimated)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline | Active comparator | Other: Stretched arm test, Device: Star shaped manual dexterity testCompletion 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. |
| Fatigue | Active comparator | Other: Stretched arm test, Device: Star shaped manual dexterity testPrior 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. |
| Stress | Active comparator | Other: Stress, Device: Star shaped manual dexterity testDuring 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. |
| Fatigue and Stress | Active comparator | Other: Stretched arm test, Other: Stress, Device: Star shaped manual dexterity testThe 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 20 and 55 years
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Stretched arm testMeasurement 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. | Other | Baseline, Fatigue, Fatigue and Stress |
| StressDuring 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 | Other | Fatigue and Stress, Stress |
| Star shaped manual dexterity testOn 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. | Device | Baseline, Fatigue, Fatigue and Stress, Stress |
Primary outcome
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.
1 secondary outcome
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
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 25 Sep 2014.
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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.
Niels Kildebro, BSc.med. principal investigator
Herlev Hospital, Copenhagen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretched arm test, Stress and Star shaped manual dexterity test in people with Manual Dexterity, run by Herlev Hospital at 1 site in Denmark.
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 1 inclusion and 5 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 25 Sep 2014. 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 Denmark. 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?
Completion time of the star shaped manual dexterity test. (time frame: up to day 10). 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 25 Sep 2014.