A randomized control trial will be conducted, for evaluating the effectiveness of the implementation of a lower back assistive exoskeleton on the caregivers working in nursing homes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
Lumbar assistive exoskeleton evaluation
IFAS/GUFE Centro Asistencial Leioa
Leioa, Bizkaia, Spain
RECRUITINGIFAS/GUFE Centro Asistencial Elorrio
Elorrio, Vizcaya, Spain
RECRUITINGChange from baseline Pain Intensity at 3 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
Time frame: At Baseline and at 3 months
Change from baseline Pain Intensity at 6 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
Time frame: At Baseline and at 6 months
Change from baseline Pain Intensity at 9 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
Time frame: At Baseline and at 9 months
Change from baseline Pain Intensity at 12 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
Time frame: At Baseline and at 12 months
Usability measured by System Usability Scale
It is a simple scale of ten items that provides a subjective global vision of the usability of the evaluated exoskeleton on a scale of 1 to 5 (1 being strongly disagree and 5 strongly agree). Higher values mean the users found the device more usable.
Time frame: Baseline, month 3, month 6, month 9, post intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
User Satisfaction measured by Quebec User Evaluation of Satisfaction with Assistive Technology
Scale to evaluate the satisfaction of the person during the use of the exoskeleton. It is made up of two subscales: the first considers eight aspects related to the support product (in this case, the exoskeleton); the second subscale evaluates four items regarding maintenance services during the use of the device. The scale goes from 1 (not satisfied at all) to 5 (very satisfied). Higher values mean that users are more satisfied.
Time frame: Baseline, month 3, month 6, month 9, post intervention
Self-reported work ability by Work Ability Index
It yields a continuous score ranging from 7 to 49 points, where higher scores indicate better work ability.
Time frame: Baseline, month 3, month 6, month 9, post intervention
Borg's CR-10 scale for perceived physical exertion at work
It measures perceived physical exertion while doing physical work in a scale ranging from 0 (nothing at all) to 10 (extremely strong).
Time frame: Baseline, month 3, month 6, month 9, post intervention
Muscular resistance of the trunk muscles measured by the "Shirado-Ito" test
It measures trunk muscle endurance based on the maximum time the participant is able to maintain a defined body position.
Time frame: Baseline, month 3, month 6, month 9, post intervention
Discomfort measured by Body Part Discomfort Scale
Survey of subjective symptoms that evaluates both the direct experience of discomfort of the person surveyed in different parts of the body, as well as the intensity of said discomfort on a scale of 0 to 10 (0 being no discomfort and 10 extremely high discomfort).
Time frame: Baseline, month 3, month 6, month 9, post intervention
Absenteeism
Days of absence from work will be collected from the official registry of the company and by the following question: "In total, how many days of work have you missed due to health reasons (injury, illness, medical consultation / treatment ...) during the last 12 weeks?". Possible answers will be: "0 days", "1-7 days", "8-30 days", "more than 30 days". In addition, number of days of absenteeism during the last 7 days (0-7) will be recorded.
Time frame: Baseline, month 3, month 6, month 9, post intervention
Musculoskeletal disorders prevalence
Prevalence of musculoskeletal injuries such as tendinopathies, unspecific low back pain
Time frame: Baseline, month 3, month 6, month 9, post intervention
Prevalence of Side Effects
Side effects secondary to the use of the exoskeleton such as: chafe, irritation, pressures.
Time frame: Baseline, month 3, month 6, month 9, post intervention