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Clinical Trials/NCT02146443
NCT02146443CompletedNot Applicable

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

Herlev Hospital1 site in 1 country31 target enrollmentStarted: June 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Locations
1
Primary Endpoint
Completion time of the star shaped manual dexterity test.

Study Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Investigator)

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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.

Intervention: Stretched arm test (Other)

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.

Intervention: Star shaped manual dexterity test (Device)

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.

Intervention: Star shaped manual dexterity test (Device)

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.

Intervention: Stretched arm test (Other)

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.

Intervention: Stress (Other)

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.

Intervention: Star shaped manual dexterity test (Device)

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.

Intervention: Stretched arm test (Other)

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.

Intervention: Stress (Other)

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.

Intervention: Star shaped manual dexterity test (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Number of errors during the completion of the star shaped manual dexterity test.(Test completion period at day 1, 4, 7 and 10)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Niels Kildebro

BSc.med., Scholar student

Herlev Hospital

Study Sites (1)

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