Cumulative Trauma DisordersNCT00167336
Developing an Instrument to Measure Personal Keyboarding Style
An observational study of Cumulative Trauma Disorders, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will develop and refine an observational assessment tool called the Personal Computer Keyboard Style (PeCKS). When completed this assessment tool will provide researchers and clinicians with a valid and reliable method to describe computer keyboarding postures and kinematics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cumulative Trauma Disorders
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2005
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Computer Users who use a computer at least 20 hours per week with or without cumulative trauma disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
This study will develop and refine an observational assessment tool called the Personal Computer Keyboard Style (PeCKS). When completed this assessment tool will provide researchers and clinicians with a valid and reliable method to describe computer keyboarding postures and kinematics.
The proposed study will be divided into two phases. Phase I will be devoted to developing and refining an instrument, the Pre-PeCKS, into a valid and reliable data gathering observational tool. In Phase II the Pre-PeCKS will be used to develop a predictive model that can discriminate between those with and without MSD-UE. The model developed will be used to select the construction and weighting of the subscales of the final instrument, the PeCKS.
Read more
Phase I - PeCKS psychometrics - reliability and validity Specific Aim 1: To evaluate inter- and intra-rater reliability and the concurrent criterion-related validity of the Pre-PeCKS.
H.1.1 The Pre-PeCKS will demonstrate acceptable reliability for the following tests:
H.1.1a. Intra-rater reliability (stability within one rater) H.1.1b. Inter-rater reliability (stability across raters) H.1.1c. Test of internal consistency (Cronbach's alpha) (stability across items)
H.1.2 The Pre-PeCKS will demonstrate good concurrent criterion-related validity - Parameters selected by raters using the Pre-PeCKS will significantly correlate with biomechanical measures (VICON™ motion recording and analysis system and force plate):
H.1.2.a. Angles and displacements identified by raters using the Pre-PeCKS will correlate with angles and displacements measured by the VICON™ motion recording and analysis system; H.1.2.b. Number of times spent performing actions as specified by raters using the Pre-PeCKS will correlate with number of times measured by a VICON™ motion recording and analysis system; H.1.2.c. Level of forceful keying as specified by raters using the Pre-PeCKS will correlate with levels of forceful keying measured with a force plate under the keyboard.
Phase II - PeCKS psychometrics - diagnostic tool development
Specific Aim 2: To use information gathered using the Pre-PeCKS to develop a diagnostic instrument that can identify those with and without MSD-UE. The major hypothesis related to Specific Aim 2 is:
H.2.1. Using information gathered with the Pre-PeCKS and knowing the disease outcome of the subjects, predictive models can be developed that discriminate between those who do and do not have MSD-UE.
Read the detailed description
This three-year study will be divided into two phases. Phase I will be devoted to developing and refining an instrument, the Pre-PeCKS, into a valid and reliable data gathering observational tool. In Phase II the Pre-PeCKS will be used to develop a predictive model that can discriminate between those with and without MSD-UE. The model developed will be used to select the construction and weighting of the subscales of the final instrument, the PeCKS. The specific aim of Phase I is to evaluate the inter- and intra- rater reliability and the concurrent criterion-related validity of the Pre-PeCKS; the specific aim of Phase II is to use information gathered using the Pre-PeCKS to develop a diagnostic instrument that can identify those with and without MSD-UE. In Phase I, 50 subjects will be digitally recorded while typing while at the same time the kinematics of their hands will be recorded using a VICON™ motion analysis system and a keyboard force plate. The video of the typing performance will be rated by independent raters using the Pre-PeCKS and reliability statistics will be calculated. Concurrent validity will be obtained by comparing the results of the VICON™ with the results of the Pre-PeCKS. In Phase II, 20 typists with MSD-UE and 20 typists without MSD-UE will be rated using the Pre-PeCKS. Variables from the Pre-PeCKS along with other variables of interest will be used to build models that can discriminate between those with and without MSD-UE. The best model will be used to assign weights to Pre-PeCKS parameters and to develop how subscores will be combined to best identify those with MSD-UE. This information will be integrated into the final tool, the PeCKS. The PeCKS can then be used to identify an individual who have keyboarding styles that have been associated with MSD-UE.
- Conditions
- Cumulative Trauma Disorders
- Keywords
- Computer, Kinematics, Instrument development, Reliability, Cumulative Trauma Disorder
- Medical subject headings
- Cumulative Trauma Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cumulative Trauma DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Investigators
- Nancy A Baker, ScD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167336
- Sponsor's protocol ID
- 0403027
- Other IDs
- K01OH007826-02
- Status last verified
- Jun 2006
- First submitted
- 9 Sep 2005
- Last updated
- 16 Dec 2015
- Results posted
- No
Publications
Baker NA, Redfern MS. Developing an observational instrument to evaluate personal computer keyboarding style. Appl Ergon. 2005 May;36(3):345-54. doi: 10.1016/j.apergo.2004.11.003.
PubMed 15854578
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Instrument to Measure Personal Keyboarding Style
- ClinicalTrials.gov ID
- NCT00167336
- Acronym / sponsor ID
- 0403027
- Conditions
- Cumulative Trauma Disorders
- Keywords
- Computer, Kinematics, Instrument development, Reliability, Cumulative Trauma Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- May 2004
- Study completion
- Mar 2005
- First posted
- 14 Sep 2005 (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.
This study will develop and refine an observational assessment tool called the Personal Computer Keyboard Style (PeCKS). When completed this assessment tool will provide researchers and clinicians with a valid and reliable method to describe computer keyboarding postures and kinematics.
The proposed study will be divided into two phases. Phase I will be devoted to developing and refining an instrument, the Pre-PeCKS, into a valid and reliable data gathering observational tool. In Phase II the Pre-PeCKS will be used to develop a predictive model that can discriminate between those with and without MSD-UE. The model developed will be used to select the construction and weighting of the subscales of the final instrument, the PeCKS.
Phase I - PeCKS psychometrics - reliability and validity Specific Aim 1: To evaluate inter- and intra-rater reliability and the concurrent criterion-related validity of the Pre-PeCKS.
H.1.1 The Pre-PeCKS will demonstrate acceptable reliability for the following tests:
H.1.1a. Intra-rater reliability (stability within one rater) H.1.1b. Inter-rater reliability (stability across raters) H.1.1c. Test of internal consistency (Cronbach's alpha) (stability across items)
H.1.2 The Pre-PeCKS will demonstrate good concurrent criterion-related validity - Parameters selected by raters using the Pre-PeCKS will significantly correlate with biomechanical measures (VICON™ motion recording and analysis system and force plate):
H.1.2.a. Angles and displacements identified by raters using the Pre-PeCKS will correlate with angles and displacements measured by the VICON™ motion recording and analysis system; H.1.2.b. Number of times spent performing actions as specified by raters using the Pre-PeCKS will correlate with number of times measured by a VICON™ motion recording and analysis system; H.1.2.c. Level of forceful keying as specified by raters using the Pre-PeCKS will correlate with levels of forceful keying measured with a force plate under the keyboard.
Phase II - PeCKS psychometrics - diagnostic tool development
Specific Aim 2: To use information gathered using the Pre-PeCKS to develop a diagnostic instrument that can identify those with and without MSD-UE. The major hypothesis related to Specific Aim 2 is:
H.2.1. Using information gathered with the Pre-PeCKS and knowing the disease outcome of the subjects, predictive models can be developed that discriminate between those who do and do not have MSD-UE.
Detailed description
This three-year study will be divided into two phases. Phase I will be devoted to developing and refining an instrument, the Pre-PeCKS, into a valid and reliable data gathering observational tool. In Phase II the Pre-PeCKS will be used to develop a predictive model that can discriminate between those with and without MSD-UE. The model developed will be used to select the construction and weighting of the subscales of the final instrument, the PeCKS. The specific aim of Phase I is to evaluate the inter- and intra- rater reliability and the concurrent criterion-related validity of the Pre-PeCKS; the specific aim of Phase II is to use information gathered using the Pre-PeCKS to develop a diagnostic instrument that can identify those with and without MSD-UE. In Phase I, 50 subjects will be digitally recorded while typing while at the same time the kinematics of their hands will be recorded using a VICON™ motion analysis system and a keyboard force plate. The video of the typing performance will be rated by independent raters using the Pre-PeCKS and reliability statistics will be calculated. Concurrent validity will be obtained by comparing the results of the VICON™ with the results of the Pre-PeCKS. In Phase II, 20 typists with MSD-UE and 20 typists without MSD-UE will be rated using the Pre-PeCKS. Variables from the Pre-PeCKS along with other variables of interest will be used to build models that can discriminate between those with and without MSD-UE. The best model will be used to assign weights to Pre-PeCKS parameters and to develop how subscores will be combined to best identify those with MSD-UE. This information will be integrated into the final tool, the PeCKS. The PeCKS can then be used to identify an individual who have keyboarding styles that have been associated with MSD-UE.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Computer Users who use a computer at least 20 hours per week with or without cumulative trauma disorders
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Dec 2015.
- Background: PubMed 15854578Baker NA, Redfern MS. Developing an observational instrument to evaluate personal computer keyboarding style. Appl Ergon. 2005 May;36(3):345-54. doi: 10.1016/j.apergo.2004.11.003.
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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.
Nancy A Baker, ScD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cumulative Trauma Disorders, run by University of Pittsburgh at 1 site in United States.
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 0 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 16 Dec 2015. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00167336, which also lists 1 linked publication.
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 16 Dec 2015.