- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01178983
Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators
In the recent decades, with technology development, computer workstation has become fundamental both at work and at home environments, and is now used routinely for many purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck and upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since it has been found that many musculoskeletal disorders are connected, among others, to biomechanical and psychosocial factors relating to a person's work environment, the literature refers to them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD include repetitive motions, awkward positions or static muscle loading over prolonged periods of time, use of high keystroke force, direct mechanical pressure, vibration and extreme temperatures. Computer operators found to be sitting statically for a long time in front of the computer and keyboard, with limited options of changing body position. Psychosocial factors have also been implicated in the workstation musculoskeletal disorders with computer operators. Workers with WRMSD may suffer from persistent pain, loss of function and work disability. Therefore, it may include changes in the employment and earnings for injured workers. The complex nature of these injuries suggests that workplace rehabilitation interventions are a crucial aspect of treatment management.
The main objective of this study is to explore the use of biofeedback intervention, based on tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be done by ANOVA Repeated Measures.
Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found effective with computer operators suffer from WRMSD.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ramat Gan, Israel, 52621
- Recruiting
- Sheba Tel Hashomer hospital - upper limb rehabilitation center
-
Contact:
- merav golombowicz
- Phone Number: 035303723
- Email: meravgo@post.tau.ac.il
-
Principal Investigator:
- yafi levanon, Phd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- computer operators who spend more than 4 hours a day working with computer
- computer operators who suffer from pain and inconvenience or injury in upper limbs, such as Lateral Epicondylitis, de Quervain disease, Carpal Tunnel Syndrome (CTS), Ulnar Tunnel Syndrome, Flexor-Extensor peritendinitis or teno-synovitis of the forearm-wrist region.
Exclusion Criteria:
- subjects who suffer from neurological injuries
- subjects who suffer from orthopedic injuries or other metabolic or autoimmune diseases, that cause joint oedema or hand numbness (pregnancy, diabetes, heart disease and arthritis).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: telebiofeedback
|
Surface electromyography (SEMG) telebiofeedback
conventional biofeedback
|
|
Active Comparator: biofeedback
|
Surface electromyography (SEMG) telebiofeedback
conventional biofeedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Posture at work environment measured by Rapid Upper LImb Assessment (RULA)
Time Frame: 15 months
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Musculoskeletal Disorders (MSD) - pain and inconvenience
Time Frame: 15 months
|
15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Merav Golombowicz, BOT, Upper Limb Rehabilitation Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-10-7334-RP-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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