Lumbar Assistive Exoskeletons in Caregiving - Clinical Trial for Healthy | NCT05473208

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Exoskeleton

About this trial

This is an interventional prevention trial for Healthy focused on measuring Low back pain, Exoskeleton, Caregiver, Nursing home, Musculoskeletal disease, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

nursing home caregivers

Exclusion Criteria:

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

Sites / Locations

IFAS/GUFE Centro Asistencial LeioaRecruiting
IFAS/GUFE Centro Asistencial ElorrioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Exoskeleton Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

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.

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.

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.

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).

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.

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).

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.

Musculoskeletal disorders prevalence

Prevalence of musculoskeletal injuries such as tendinopathies, unspecific low back pain

Prevalence of Side Effects

Side effects secondary to the use of the exoskeleton such as: chafe, irritation, pressures.

Full Information

NCT ID

NCT05473208

First Posted

July 20, 2022

Last Updated

January 4, 2023

Sponsor

University of the Basque Country (UPV/EHU)

Collaborators

Diputación Foral de Bizkaia

1. Study Identification

Unique Protocol Identification Number

NCT05473208

Brief Title

Lumbar Assistive Exoskeletons in Caregiving

Acronym

ExoCare

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 11, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of the Basque Country (UPV/EHU)

Collaborators

Diputación Foral de Bizkaia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Low Back Pain, Musculoskeletal Pain, Musculoskeletal Injury

Keywords

Low back pain, Exoskeleton, Caregiver, Nursing home, Musculoskeletal disease, Quality of life

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Arm Title

Exoskeleton Group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Exoskeleton

Intervention Description

Lumbar assistive exoskeleton evaluation

Primary Outcome Measure Information:

Title

Change from baseline Pain Intensity at 3 months

Description

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

Time Frame

At Baseline and at 3 months

Title

Change from baseline Pain Intensity at 6 months

Description

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

Time Frame

At Baseline and at 6 months

Title

Change from baseline Pain Intensity at 9 months

Description

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

Time Frame

At Baseline and at 9 months

Title

Change from baseline Pain Intensity at 12 months

Description

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

Time Frame

At Baseline and at 12 months

Secondary Outcome Measure Information:

Title

Usability measured by System Usability Scale

Description

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.

Time Frame