A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]

A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL] - A study of safety and efficacy of HAL for hemiparesis due to the brain disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022410

Enrollment

Registered

2016-05-23

Start date

2016-09-21

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

Stroke (Cerebral infarction, Cerebral hemorrhage)

Interventions

HAL group performed gait training using the HAL 3 times a week with a total of 9 HAL training sessions (3 weeks). Conventional group performed conventional physical therapy 3 times a week with a tota

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke in the acute phase. 2)Age:40-80 years old 3)Time since stroke onset within 7-14 days. 4)Functional Ambulation Category (FAC) 1-2 5)Patient can ensure more than 3 weeks from intervention initiation. 6)Patient with a score of more than 4 on the FAC prior to stroke. 7)Patient can consent by a document. If the handwriting is difficult due to the paralysis, it is assumed to obtain a document consent from ghost-writing user. 8)Patient who can be suitable for HAL (only HAL group)

Exclusion criteria

Exclusion criteria: 1)It is difficult to perform the voluntary movement of the limbs in accordance with the instructions due to the disturbance of consciousness. 2)Patients has a complication, for example, severe cardiac disease and musculoskeletal system which can disturb the treatment using HAL. 3)Patients who investigator or sub investigator deemed inappropriate In this clinical trial. 4)Patients received magnetic stimulation, electrical stimulation and so no, neuromodulation therapy prior to the this study.

Design outcomes

Primary

Measure	Time frame
Functional Ambulation Category (FAC)	—

Secondary

Measure	Time frame
Brunnstrom stage (BRs) 12grade hemiplesia functional test NIHSS Fugl-meyer assessnment (FMA) 6m-Gait speed, Stride, Cadence, Gait-form Gait distance for 6 min modified Rankin Scale (mRS) Barthel Index (BI) motor Functional Independence Measure (motor FIM) MMSE Duration of hospitalization and research Frequency of HAL treatment and conventional physiotherapy Adverse event EMG TMS-MEP F wave, H wave EEG fMRI, resting-state fMRI, DTI Oxidatiove stress index Platelet aggregation	—

Measure

Time frame

Brunnstrom stage (BRs) 12grade hemiplesia functional test NIHSS Fugl-meyer assessnment (FMA) 6m-Gait speed, Stride, Cadence, Gait-form Gait distance for 6 min modified Rankin Scale (mRS) Barthel Index (BI) motor Functional Independence Measure (motor FIM) MMSE Duration of hospitalization and research Frequency of HAL treatment and conventional physiotherapy Adverse event EMG TMS-MEP F wave, H wave EEG fMRI, resting-state fMRI, DTI Oxidatiove stress index Platelet aggregation

—

Countries

Japan

Contacts

Public ContactAiki Marushima

Faculty of Medicine, University of Tsukuba Department of Neurosurgery and Stroke

aiki.marushima@md.tsukuba.ac.jp029-853-3220

Outcome results

None listed

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