RCT of HAL Lumbar Type

JRCT ID: jRCTs072230134

Registered date:28/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cases with cognitive decline or mild cognitive impairment
• Date of first enrollment: 28/03/2024
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Research collaborators will wear the HAL waist type and perform either cybernic voluntary movement training (CVC training) or movement training in autonomous robot mode (CAC training).
CVC mode: When a person attempts to move their body, their intention to move is transmitted as a nervous system command signal of a weak ionic current to the brain, spinal cord, motor nerves, and muscles, and ultimately the musculoskeletal system moves. At that time, weak bioelectrical potential signals also reach the skin surface, so HAL detects these weak bioelectrical potential signals with a sensor attached to the wearer's skin surface and utilizes this to function. As a result, when the wearer attempts to move his or her body, HAL moves according to the wearer's intention to move. Since HAL is in close contact with the body, it is driven by the wearer's will and at the same time moves the parts it is attached to, such as the legs.
In CVC training, biopotential signals from the lumbar erector spinae muscles of research participants are obtained from electrodes attached to their lower backs, and based on the biopotential signals, the HAL lumbar type supports the research participants' standing movements. Have the test subject perform training while receiving support from the HAL waist type.
CAC mode: HAL operates according to a program prepared in advance based on the analysis results of human basic movement patterns and movement mechanisms.
In CAC training, electrodes are pasted on the waists of research participants, but biopotential signals are not acquired, and training is performed while receiving movement assistance from the autonomous control of the HAL waist type.
Both the CVC training group and the CAC training group performed 2 sets of 10 repetitions each of trunk forward and back bending exercises in a sitting position, standing and sitting exercises from a chair, and squats once a week. The duration of one training session is 20 to 30 minutes.

Outcome(s)

• Primary Outcome: The main evaluation item is the effect size in the correct answer rate of lure condition of the hippocampal function test from the baseline to the second evaluation.

Secondary Outcome

1) The 10 Metre Walk Test
2) Berg Balance Scale
3) Five Times Sit to Stand Test
4) Timed Up & Go Test
5) Clinical Dementia Scale
6) Mini-Mental State Examination (MMSE)
7) The hippocampal function test
8) Measurement of drebrin concentration in blood
The following the amount of changes in scores 1) to 8) above will be evaluated: 1) from baseline to second evaluation, 2) from baseline to final evaluation, 3) from second evaluation to final evaluation.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 95age old
• Gender: Both

Include criteria

1) Participants aged 40 years or older and younger than 95 years old
2) Participants who understand the instructions for hippocampal function testing and are able to perform the test.
3) Participants who can walk independently on level ground for more than 15 meters
4) Participants with support level 1 or below based on nursing care certification
5) Participants with an MMSE score of 22 points or more or a CDR score of 0.5 or less
6) Participants who can generate free will to improve limb trunk function or cognitive function
7) Participants who can imagine and execute independent movements based on free will

Exclude criteria

1) Participants with severe skeletal deformities such as hip osteoarthritis, knee osteoarthritis, knee osteoarthritis, and scoliosis
2) Participants who cannot perform hippocampal function tests
3) If the person or his/her representative requests to refuse participation.
4) Participants using implanted medical devices (cardiac pacemaker, etc.)
5) Participants who fall under the adult guardianship system 'assistance/curator/guardianship'

Related Information

• Primary Sponsor: Ishiuchi Shogo