Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators
Computer settings points to a number of risk factors which may induce the development of Work related MSD (WRMSD). In light of the expanded use of computers and the increased occurrence of Upper Extremity (UE) WRMSD among computer operators various intervention programs have been developed and tested. Nevertheless, many of these programs do not meet the criteria of quality and level of evidence.
The main objective of this study is to use simultaneously a three dimensional (3D) kinematic analysis system, surface electromyography (SEMG) and fingertip force measurement system (Flexiforce) while typing, to test the efficacy of primary and secondary preventive intervention programs aimed at reducing MSD among computer operators.
Work hypothesis: Significant score differences will be found on the evaluation parameters between the research group which underwent ergonomic training with biofeedback, the group without feedback, and the control group.The evaluated parameters will correlate with the appearance of MSD symptoms and pain and will affect level of function.
The study will include 66 participants, programmers and computer engineers. The participants will be assigned randomly to one of three groups: 1) participants will receive ergonomic training with biofeedback; 2) participants will receive ergonomic training without biofeedback; and 3) control group, without intervention. Each group will consist of 22 participants.
Treatment efficacy will be tested both at work and in the motion lab. In the lab, 3D kinematic measurements and fingertip forces relevant to typing while entering a standard text will be measured. At the work site, anthropometric and measurements, work station measurements, posture observation and questionnaires about, psychosocial status, function and pain level will be filled The preventive program will be performed at the workstation after the preliminary data collection phase. The program will consist of one group meeting at the workplace for all employees participating in the study, and individual instruction at the workstation, including 3-6 meetings for the two research groups. Data will be collected before and after the intervention program.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Ramat Gan, Israele
- Reclutamento
- Motion Laboratory, Sheba medical center
-
Investigatore principale:
- Uri givon, MD
-
Contatto:
- Yafi Levanon, MSc
- Numero di telefono: ++972-52- 6666598
- Email: yafil@post.tau.ac.il
-
Investigatore principale:
- Ron Frimer, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- subjects working more than four hours per day in front of a computer and are right-hand dominant.
- Healthy or suffering from diagnoses of UE-MSD. (e.g. Rotator cuff syndrome , Lateral epicondylitis, Cubital tunnel syndrome, Carpal tunnel syndrome, Flexor-extensor peri-tendinitis or teno-synovitis of the forearm-wrist region, De Quervain's disease and Nonspecific MSD
Exclusion Criteria:
- Participants suffering from orthopedic injury or neurological deficit (with the exception of the diagnosis mentioned above).
- Medical conditions that cause swelling of the joints or hand numbness (pregnancy, diabetes, heart condition, arthritis).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Ergonomic consulting
Ergonomic consulting without biofeedback
|
Standard ergonomic intervention , how to sit and work with computers
Altri nomi:
|
|
Sperimentale: Ergonomic consulting with biofeedback
Ergonomic intervention with biofeedback
|
Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)
Altri nomi:
|
|
Nessun intervento: general instructions
general instructions with no intervention
|
general instructions no intervention
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Musculoskeletal disorders measurement (MSD score)
Lasso di tempo: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
The MSD score of the whole body will be collected out of a self administrated questionnaire in the first meeting before intervention and in the last meeting.
the score indicates the number of painful body regions that were harmful in the last week before answering the Questionnaire.
Negative differences between post and pre intervention will indicate improvement in pain.
|
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rapid Upper Limb Assessment (RULA)score
Lasso di tempo: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one
|
The RULA is an observation that assess the posture at work.
The assessment will be held in the work place in the first meeting before intervention and in the last meeting.
The score ranged between 0-7, higher score indicates higher risk for MSD.
Negative differences between post and pre intervention will indicate improvement in posture at work.
|
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one
|
|
Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system.
Lasso di tempo: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
The Kinematics of the upper extremity (fingers, wrist and elbow) will be measured in the second and in the last meeting at the motion laboratory.
The second meeting will be not more than 2 weeks after the first meeting.R.O.M will be measured in degrees and the angular velocity will be presented in degrees per seconds.
.Negative differences between post and pre intervention indicates improvement in R.O.M and angular velocity.
|
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
|
Muscle activity
Lasso di tempo: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
The muscle activity amplitude of the wrist and finger extensors and the upper trapezius will be measured and collected in the second meeting at the motion laboratory simultaneously with the kinematic data.The muscle amplitude will be presented as percentile of the Maximal Voluntary Contraction (MVC) of the same muscles.
Higher percentage of muscle activity will indicate higher muscle load.
Negative differences between post and pre intervention indicates improvement in muscle activity.
|
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
|
Psychosocial job characteristics assessment (DCSQ)
Lasso di tempo: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
The D.C.S.Q will be measured by a self administrated questionnaire in the first meeting before intervention and in the last meeting.
The job demands score range between 5-25 and the decision latitude score range between 8-40.
Low level of job demands and high decision latitude indicates low level of stress at work.
|
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Yafi Levanon, MsC, Sheba Medical Center , Tel aviv University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 757-2008-IDF-CTIL
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .