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| Name | Class |
|---|---|
| Diputación Foral de Bizkaia | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants randomly assigned to control group will not wear an exoskeleton during working hours. | |
| Exoskeleton Group | Experimental | Participants randomly assigned to exoskeleton group will be given instructions and explanations on how to use/adjust/loosen the exoskeleton, and after a period of familiarisation, they will be wearing an exoskeleton during their working hours for a period of one year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton | Device | Lumbar assistive exoskeleton evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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 | 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 | 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 | 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 | At Baseline and at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, month 3, month 6, month 9, post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Rodriguez Larrad, PhD | Contact | 0034946017925 | ana.rodriguez@ehu.eus | |
| Maialen Aiestaran, MsC | Contact | 0034946017925 | maialen.aiestaran@ehu.eus |
| Name | Affiliation | Role |
|---|---|---|
| Ana Rodriguez Larrad, PhD | Professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IFAS/GUFE Centro Asistencial Leioa | Recruiting | Leioa | Bizkaia | 48940 | Spain | |
| IFAS/GUFE Centro Asistencial Elorrio |
IPD sharing under acceptable request
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059352 | Musculoskeletal Pain |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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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.
| 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. | 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. | 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). | 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. | 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). | 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. | Baseline, month 3, month 6, month 9, post intervention |
| Musculoskeletal disorders prevalence | Prevalence of musculoskeletal injuries such as tendinopathies, unspecific low back pain | 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. | Baseline, month 3, month 6, month 9, post intervention |
| Recruiting |
| Elorrio |
| Vizcaya |
| 48230 |
| Spain |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |