Clinical investigation of the physical work load in caregivers using the robotic device.

Phase 1

Recruiting

• Conditions: caregiver/elderly, care,receiver; elderly, care,receiver; D000368

• Registration Number: JPRN-jRCT1050220118
• Lead Sponsor: Ohata Koji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Caregiver
1.Individuals who have more than six months of work experience as a certified care worker.
2.18 years old or older at the time of obtaining consent.
2.Person who needs care
1.Individuals who need full assistance during the transfer.
2.Individuals who needs to be supported by two caregivers.
3.Individuals with a height from 140 cm to less than 180 cm and a weight of less than 120 kg.
4.40 years old or older at the time of obtaining consent.

Exclusion Criteria

Caregiver
1.Individuals whose transfer assistance is limited by orthopedic problems such as pain
Person who needs care
1.Individuals who have had adverse events such as fractures associated with transfer during past one year.
2.Individuals who have difficulty to assist in normal transfer due to severe limitation of range of motion.
3.Individuals who have frequent severe epilepsy and seizures and are expected to have seizures during measurement in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical Work Load assessment during transfer assistance for caregivers

Secondary Outcome Measures

Name	Time	Method
questionnaire concerned with assisting transfer for caregivers<br>questionnaire for survey of care recipients' attitudes for caregivers<br>Change of heart rate during transfer both in caregiver and elderly<br>Electromyographic activity during transferring<br>relationship between Barthel Index for elderly and Physical Work Load, questionnaire concerned with assisting transfer for caregivers or questionnaire for survey of care recipients' attitudes for caregivers.<br>Test-retest reliability for Physical Work Load, questionnaire concerned with assisting transfer for caregivers and questionnaire for survey of care recipients' attitudes for caregivers.<br>relationship between physiological measurements and Physical Work Load, questionnaire concerned with assisting transfer for caregivers or questionnaire for survey of care recipients' attitudes for caregivers.