Lumbar Assistive Exoskeletons in Caregiving

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Lumbar Assistive Exoskeleton in Nursing Home Caregivers: Randomized Control Trial

Conditions
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Healthy, Low Back Pain, Musculoskeletal Pain, Musculoskeletal Injury

Intervention / Treatment
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* Device: Exoskeleton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nursing home caregivers Exclusion Criteria: pregnancy presence of condition that prevents from the use of a lumbar exoskeleton

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Participants randomly assigned to control group will not wear an exoskeleton during working hours. | |
| Experimental: Exoskeleton Group<br>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. | Device: Exoskeleton<br>* Lumbar assistive exoskeleton evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Exoskeleton, Caregiver, Nursing home, Musculoskeletal disease, Quality of life