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

NCT02146443 | Completed DMC

• 1 other identifier: STAR-222
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Manual Dexterity

Keywords

Manual dexterity; hand to eye coordination; stress; fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of errors during the completion of the star shaped manual dexterity test.

  Test completion period at day 1, 4, 7 and 10

Study Arms (4)

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.

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.

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.

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.

Other: Stretched arm test; Other: Stress; Device: Star shaped manual dexterity test

Interventions

Stretched arm test OTHER

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.

Baseline; Fatigue; Fatigue and Stress

Stress OTHER

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

Fatigue and Stress; Stress

Star shaped manual dexterity test DEVICE

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.

Baseline; Fatigue; Fatigue and Stress; Stress

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 and 55 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Niels Kildebro, BSc.med.

  Herlev Hospital, Copenhagen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc.med., Scholar student

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

DK (1)