Healthy, Low Back Pain, Musculoskeletal Pain, Musculoskeletal Injury
Conditions
Keywords
Low back pain, Exoskeleton, Caregiver, Nursing home, Musculoskeletal disease, Quality of life
Brief summary
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.
Interventions
DEVICEExoskeleton
Lumbar assistive exoskeleton evaluation
Sponsors
Diputación Foral de Bizkaia
University of the Basque Country (UPV/EHU)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigators in charge of doing the statistical analysis and assessing the outcome measures (e.g., physical performance tests) will be blinded to group allocation. Due to the characteristics of the study (use of the exoskeleton during working hours) blinding of the participants is not possible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* nursing home caregivers
Exclusion criteria
* pregnancy * presence of condition that prevents from the use of a lumbar exoskeleton
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Pain Intensity at 3 months | At Baseline and 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 |
| Change from baseline Pain Intensity at 6 months | At Baseline and 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 |
| Change from baseline Pain Intensity at 9 months | At Baseline and 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 |
| Change from baseline Pain Intensity at 12 months | At Baseline and 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular resistance of the trunk muscles measured by the Shirado-Ito test | Baseline, month 3, month 6, month 9, post intervention | It measures trunk muscle endurance based on the maximum time the participant is able to maintain a defined body position. |
| Discomfort measured by Body Part Discomfort Scale | Baseline, month 3, month 6, month 9, post intervention | 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). |
| Usability measured by System Usability Scale | Baseline, month 3, month 6, month 9, post intervention | 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. |
| Musculoskeletal disorders prevalence | Baseline, month 3, month 6, month 9, post intervention | Prevalence of musculoskeletal injuries such as tendinopathies, unspecific low back pain |
| Prevalence of Side Effects | Baseline, month 3, month 6, month 9, post intervention | Side effects secondary to the use of the exoskeleton such as: chafe, irritation, pressures. |
| Absenteeism | Baseline, month 3, month 6, month 9, post intervention | 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. |
| User Satisfaction measured by Quebec User Evaluation of Satisfaction with Assistive Technology | Baseline, month 3, month 6, month 9, post intervention | 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. |
| Self-reported work ability by Work Ability Index | Baseline, month 3, month 6, month 9, post intervention | It yields a continuous score ranging from 7 to 49 points, where higher scores indicate better work ability. |
| Borg's CR-10 scale for perceived physical exertion at work | Baseline, month 3, month 6, month 9, post intervention | It measures perceived physical exertion while doing physical work in a scale ranging from 0 (nothing at all) to 10 (extremely strong). |
Countries
Spain
Contacts
Primary ContactAna Rodriguez Larrad, PhD
Backup ContactMaialen Aiestaran, MsC
Outcome results
None listed