Lumbar Assistive Exoskeletons in Caregiving (ExoCare)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Low Back Pain; Musculoskeletal Pain; Musculoskeletal Injury
• Intervention / Treatment: Device: Exoskeleton

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Rodriguez Larrad, PhD; Phone Number: 0034946017925; Email: ana.rodriguez@ehu.eus
• Study Contact Backup: Name: Maialen Aiestaran, MsC; Phone Number: 0034946017925; Email: maialen.aiestaran@ehu.eus

Study Locations

• Spain
  • Bizkaia
    • Leioa, Bizkaia, Spain, 48940
      • Recruiting
      • IFAS/GUFE Centro Asistencial Leioa
  • Vizcaya
    • Elorrio, Vizcaya, Spain, 48230
      • Recruiting
      • IFAS/GUFE Centro Asistencial Elorrio
      • Contact: Phone Number: +34 946583231

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• nursing home caregivers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of the Basque Country (UPV/EHU)
• Collaborators: Diputación Foral de Bizkaia
• Investigators: Study Director: Ana Rodriguez Larrad, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Low back pain; Quality of life; Caregiver; Exoskeleton; Nursing home; Musculoskeletal disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Back Pain; Low Back Pain; Musculoskeletal Pain
• Other Study ID Numbers: ExoCare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD sharing under acceptable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No