Lumbar Assistive Exoskeletons in Caregiving

NCT05473208 | Unknown DMC

• 1 other identifier: ExoCare
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy; Low Back Pain; Musculoskeletal Pain; Musculoskeletal Injury

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Usability measured by System Usability Scale

  Baseline, month 3, month 6, month 9, post intervention

• User Satisfaction measured by Quebec User Evaluation of Satisfaction with Assistive Technology

  Baseline, month 3, month 6, month 9, post intervention

• Self-reported work ability by Work Ability Index

  Baseline, month 3, month 6, month 9, post intervention

• Borg's CR-10 scale for perceived physical exertion at work

  Baseline, month 3, month 6, month 9, post intervention

• Muscular resistance of the trunk muscles measured by the "Shirado-Ito" test

  Baseline, month 3, month 6, month 9, post intervention

Study Arms (2)

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.

Device: Exoskeleton

Interventions

Exoskeleton DEVICE

Lumbar assistive exoskeleton evaluation

Exoskeleton Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nursing home caregivers

You may not qualify if:

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

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Diputación Foral de Bizkaia: collaborator

Study Sites (2)

IFAS/GUFE Centro Asistencial Leioa

Leioa, Bizkaia, 48940, Spain

RECRUITING

IFAS/GUFE Centro Asistencial Elorrio

Elorrio, Vizcaya, 48230, Spain

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Musculoskeletal Pain; Musculoskeletal Diseases

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Ana Rodriguez Larrad, PhD

  Professor

  STUDY DIRECTOR

Central Study Contacts

Ana Rodriguez Larrad, PhD

CONTACT

0034946017925; ana.rodriguez@ehu.eus

Maialen Aiestaran, MsC

CONTACT

0034946017925; maialen.aiestaran@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: October 11, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2024
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

ES (2)