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

JRCT ID: jRCT1050220117

Registered date:17/11/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: caregiver, elderly, care-receiver
• Date of first enrollment: 09/11/2022
• Target sample size: 32
• Study type: Interventional
• Intervention(s): The participated caregiver transfers the elderly people with using assistance robot [Hug T-1]. The number of uses of this robot are at least 5 times or more during the investigating period. The intervention period is 2 weeks.

Outcome(s)

• Primary Outcome: Physical Work Load assessment during transfer assistance for caregivers

Secondary Outcome

questionnaire concerned with assisting transfer for caregivers
questionnaire for survey of care recipients' attitudes for caregivers
Change of heart rate during transfer both in caregiver and elderly
Electromyographic activity during transferring
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.
Test-retest reliability for Physical Work Load, questionnaire concerned with assisting transfer for caregivers and questionnaire for survey of care recipients' attitudes for caregivers.
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.
frequency and situation of assisting transfer by caregivers.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Caregiver
1.Individuals who have more than six months of work experience as a certified care worker.
Person who needs care
1.Individuals who need to be supported during the transfer.
2.Individuals who are able to sit independently or with minimal support.
3.Individuals with a height from 140 cm to less than 180 cm and a weight of less than 100 kg.

Exclude 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 occurred loss of consciousness due to orthostatic hypotension associated with transfer during past one year.
3.Individuals who cannot sit more than 30 minutes due to respiratory and/or cardiovascular diseases.
4.Individuals who have difficulty to assist in normal transfer due to severe limitation of range of motion.
5.Individuals who have frequent severe epilepsy and seizures and are expected to have seizures during measurement in this study.
6.Individuals with cognitive impairment who have difficulty understanding the content of study.

Related Information

• Primary Sponsor: Koji Ohata
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development