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RCT of HAL Lumbar Type

Specified Clinical Research on the effectiveness of improving cognitive function by motor function training using the Wearable Cyborg with HAL Lumbar Type

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072230134
Enrollment
80
Registered
2024-03-28
Start date
2024-03-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cases with cognitive decline or mild cognitive impairment MCI, dementia

Interventions

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
exercise, training

Sponsors

Ishiuchi Shogo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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'

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactMasahiko Nishimura

University of the Ryukyus Hospital

h109932@med.u-ryukyu.ac.jp+81-98-895-1171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026