Lumbar Assistive Exoskeletons in Caregiving

Not Applicable

Recruiting

• Conditions: Low Back Pain; Musculoskeletal Injury; Healthy; Musculoskeletal Pain
• Interventions: Device: Exoskeleton

• Registration Number: NCT05473208
• Lead Sponsor: University of the Basque Country (UPV/EHU)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Study Start: 2022-10-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-05
• Primary Completion: 2023-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• nursing home caregivers

Exclusion Criteria

• pregnancy
• presence of condition that prevents from the use of a lumbar exoskeleton

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exoskeleton Group	Exoskeleton	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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).

Trial Locations

Locations (2)

IFAS/GUFE Centro Asistencial Leioa; 🇪🇸 Leioa, Bizkaia, Spain

IFAS/GUFE Centro Asistencial Elorrio; 🇪🇸 Elorrio, Vizcaya, Spain