Lumbar Assistive Exoskeletons in Caregiving

Healthy Clinical Trial

— ExoCare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473208
• Other study ID #: ExoCare
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: University of the Basque Country (UPV/EHU)
• Contact: Ana Rodriguez Larrad, PhD
• Phone: 0034946017925
• Email: ana.rodriguez[@]ehu.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• nursing home caregivers

Exclusion Criteria:

• pregnancy

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

Related Conditions & MeSH terms

• Back Pain
• Healthy
• Low Back Pain
• Musculoskeletal Injury
• Musculoskeletal Pain

Intervention

Device:
• Exoskeleton
Lumbar assistive exoskeleton evaluation

Locations

Country	Name	City	State
Spain	IFAS/GUFE Centro Asistencial Elorrio	Elorrio	Vizcaya
Spain	IFAS/GUFE Centro Asistencial Leioa	Leioa	Bizkaia

Sponsors (2)

Lead Sponsor	Collaborator
University of the Basque Country (UPV/EHU)	Diputación Foral de Bizkaia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Musculoskeletal disorders prevalence	Prevalence of musculoskeletal injuries such as tendinopathies, unspecific low back pain	Baseline, month 3, month 6, month 9, post intervention
Secondary	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