ExoCare: Lumbar Assistive Exoskeletons in Caregiving

Sponsor

University of the Basque Country (UPV/EHU) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05473208

Collaborator

Diputación Foral de Bizkaia (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Low Back Pain Musculoskeletal Pain Musculoskeletal Injury	Device: Exoskeleton	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group Participants randomly assigned to control group will not wear an exoskeleton during working hours.
Experimental: Exoskeleton Group 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 Lumbar assistive exoskeleton evaluation

Arm

Intervention/Treatment

No Intervention: Control Group

Participants randomly assigned to control group will not wear an exoskeleton during working hours.

Experimental: Exoskeleton Group

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

Lumbar assistive exoskeleton evaluation

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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).
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).
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.
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.