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The Effect of Alternative Keyboards on Discomfort and Typing Kinematics

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ClinicalTrials.gov Identifier: NCT00801983
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Collaborator:
National Institute for Occupational Safety and Health (NIOSH/CDC)
Information provided by (Responsible Party):
Nancy Baker, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Pain
Intervention: Device: Alternative Keyboard

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A (Typical/Alternative) Subject receives typical keyboard for 5-6 months first and alternative keyboard second for 5-6 months (total 12 months in study
Group B (Alternative/Typical) Subject receives alternate keyboard for 5-6 months first and typical keyboard second for 5-6 months (total 12 months in study

Participant Flow for 2 periods

Period 1:   Period 1
    Group A (Typical/Alternative)   Group B (Alternative/Typical)
STARTED   44   41 
COMPLETED   40   33 
NOT COMPLETED   4   8 
Lost to Follow-up                2                0 
Withdrawal by Subject                2                8 

Period 2:   Period 2
    Group A (Typical/Alternative)   Group B (Alternative/Typical)
STARTED   40   33 
COMPLETED   38   32 
NOT COMPLETED   2   1 
Withdrawal by Subject                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
GEE analyses allows a subjects inclusion even if they did not complete the full trial. Although we had a total of 15 subjects not complete the full trial we had sufficient data on 77 subjects to complete the GEE statistical analyses. With the crossover design we compared 77 subjects using the standard keyboard to 77 subjects using the alternative

Reporting Groups
  Description
Group A Subject receives typical keyboard first (0-6 months) and alternative keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
Group B Subject receives alternative keyboard first (0-6 months) and typical keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   37   77 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.3  (12.9)   45.6  (11.9)   44.4  (12.4) 
Gender 
[Units: Participants]
     
Female   36   35   71 
Male   4   2   6 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   3   5   8 
White   36   31   67 
More than one race   0   1   1 
Unknown or Not Reported   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   0   1 
Not Hispanic or Latino   39   37   76 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   40   37   77 
Avg Computer Use 
[Units: Hrs/day]
Mean (Standard Deviation)
 6.3  (1.1)   6.1  (1.5)   6.2  (1.3) 
Typing Speed 
[Units: Participants]
     
Slow   7   3   10 
Moderately Fast   16   14   30 
Fast   11   12   23 
Don't know   6   8   14 
Baseline Discomfort 
[Units: Participants]
     
Neck (Yes)   36   36   72 
Back (Yes)   33   33   66 
Right arm hand (Yes)   33   36   69 
Left Arm hand (Yes)   22   24   46 


  Outcome Measures

1.  Primary:   Musculoskeletal Discomfort   [ Time Frame: 6 months and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Nancy Baker
Organization: University of Pittsburgh
phone: 412 383-6607
e-mail: nab36@pitt.edu



Responsible Party: Nancy Baker, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00801983     History of Changes
Other Study ID Numbers: 08030467
R01OH008961 ( U.S. NIH Grant/Contract )
First Submitted: December 3, 2008
First Posted: December 4, 2008
Results First Submitted: May 19, 2014
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014