HealthyExoCareNCT05473208
Lumbar Assistive Exoskeletons in Caregiving
A study testing Exoskeleton in people with Healthy and Low Back Pain, run by University of the Basque Country (UPV/EHU) at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Low Back Pain, Musculoskeletal Pain
- What is being tested?
- Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 11 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nursing home caregivers
Who cannot join
- pregnancy
- presence of condition that prevents from the use of a lumbar exoskeleton
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
IFAS/GUFE Centro Asistencial Elorrio
Elorrio, Vizcaya, 48230
+34 946583231
- Recruiting
IFAS/GUFE Centro Asistencial Leioa
Leioa, Bizkaia, 48940
About this study
Official title: "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.
- Conditions
- Healthy, Low Back Pain, Musculoskeletal Pain, Musculoskeletal Injury
- Being tested
- Exoskeleton
- Keywords
- Low back pain, Exoskeleton, Caregiver, Nursing home, Musculoskeletal disease, Quality of life
- Medical subject headings
- Low Back Pain, Musculoskeletal Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoskeletonDevice
Lumbar assistive exoskeleton evaluation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants randomly assigned to control group will not wear an exoskeleton during working hours. |
| Exoskeleton Group | Experimental | 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. Receives: Device: Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: At Baseline and at 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, month 3, month 6, month 9, post intervention
Musculoskeletal disorders prevalence
Prevalence of musculoskeletal injuries such as tendinopathies, unspecific low back pain
Measured: 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.
Measured: Baseline, month 3, month 6, month 9, post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start11 Oct 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Collaborators
- Diputación Foral de Bizkaia
- Responsible party
- Principal investigator, Maialen Aiestaran, MsC, University of the Basque Country (UPV/EHU)
- Investigators
- Ana Rodriguez Larrad, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473208
- Sponsor's protocol ID
- ExoCare
- Acronym
- ExoCare
- Status last verified
- Jan 2023
- First submitted
- 20 Jul 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing under acceptable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Lumbar Assistive Exoskeleton in Nursing Home Caregivers: Randomized Control Trial"
- ClinicalTrials.gov ID
- NCT05473208
- Acronym / sponsor ID
- ExoCare / ExoCare
- Conditions
- Healthy, Low Back Pain, Musculoskeletal Pain, Musculoskeletal Injury
- Keywords
- Low back pain, Exoskeleton, Caregiver, Nursing home, Musculoskeletal disease, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Collaborators
- Diputación Foral de Bizkaia
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants randomly assigned to control group will not wear an exoskeleton during working hours. |
| Exoskeleton Group | Experimental | Device: ExoskeletonParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nursing home caregivers
Key exclusion criteria (2 listed)
- pregnancy
- presence of condition that prevents from the use of a lumbar exoskeleton
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoskeletonLumbar assistive exoskeleton evaluation | Device | Exoskeleton Group |
Primary outcome
Change from baseline Pain Intensity at 3 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
9 secondary outcomes
Usability measured by System Usability Scale
Time frame: Baseline, month 3, month 6, month 9, post intervention
User Satisfaction measured by Quebec User Evaluation of Satisfaction with Assistive Technology
Time frame: Baseline, month 3, month 6, month 9, post intervention
Self-reported work ability by Work Ability Index
Time frame: Baseline, month 3, month 6, month 9, post intervention
Borg's CR-10 scale for perceived physical exertion at work
Time frame: Baseline, month 3, month 6, month 9, post intervention
Muscular resistance of the trunk muscles measured by the "Shirado-Ito" test
Time frame: Baseline, month 3, month 6, month 9, post intervention
Discomfort measured by Body Part Discomfort Scale
Time frame: Baseline, month 3, month 6, month 9, post intervention
Absenteeism
Time frame: Baseline, month 3, month 6, month 9, post intervention
Musculoskeletal disorders prevalence
Time frame: Baseline, month 3, month 6, month 9, post intervention
Prevalence of Side Effects
Time frame: Baseline, month 3, month 6, month 9, post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Undecided. IPD sharing under acceptable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rodriguez Larrad, PhD study director
Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton in people with Healthy and Low Back Pain, run by University of the Basque Country (UPV/EHU) at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Rodriguez Larrad, PhD (0034946017925, ana.rodriguez@ehu.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Pain Intensity at 3 months (time frame: At Baseline and at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.