UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060873 |
|---|---|
| Receipt number | R000069649 |
| Scientific Title | Observational Evaluation of Rehabilitation Using the Robot Suit HAL in Patients with Brain Injury |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/09 16:05:49 |
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Basic information
Public title
A Study Observing the Rehabilitation Course Using the Robot Suit HAL in Patients with Brain Injury
Acronym
HAL Rehabilitation Observation Study
Scientific Title
Observational Evaluation of Rehabilitation Using the Robot Suit HAL in Patients with Brain Injury
Scientific Title:Acronym
HAL Brain Injury Observational Study
Region
| Japan |
Condition
Condition
patients with brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantitatively assess the temporary improvement in motor function induced by HAL-assisted movement in patients with brain injury, and to evaluate the feasibility of rehabilitation using the HAL system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gait ability
Key secondary outcomes
balance ability, postural balance, balance function
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have sustained a brain injury and are currently hospitalized at Tokushima University Hospital.
Patients with lower-limb paralysis who have difficulty achieving independent ambulation.
Adult patients who can understand the explanation and provide informed consent, or minors for whom consent can be obtained from a parent or legal guardian.
Patients whose body size allows safe and appropriate fitting of the HAL device.
Patients who are able to undergo standard rehabilitation therapies such as physical therapy, occupational therapy, and orthotic therapy.
Patients who will receive rehabilitation using HAL as part of routine clinical care.
Key exclusion criteria
Uncontrolled cardiovascular disease.
Uncontrolled respiratory disease.
Cognitive impairment that makes it difficult to understand explanations or follow instructions.
Moderate to severe joint disorders, such as significant joint contractures.
Moderate to severe involuntary movements, ataxia, or postural reflex disturbances.
Severe spasticity.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Takagi |
Organization
Tokushima University Hospital
Division name
Department of Neurosurgery
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima Prefecture, Japan
TEL
088-633-7149
neuros@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Takagi |
Organization
Tokushima University Hospital
Division name
Department of Neurosurgery
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima Prefecture, Japan
TEL
088-633-7149
Homepage URL
neuros@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Self-financing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture, Japan
Tel
088-615-8512
first-ec@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study conducted as part of routine clinical rehabilitation using the HAL system in patients with brain injury. The aim is to clarify the temporary effects of HAL-assisted movement on motor function and to evaluate the feasibility of HAL-based rehabilitation. Standard clinical assessments, including gait and balance evaluations, neuro-radiological examinations, and neuropsychological tests, will be performed. No external funding is provided, and the study is carried out within the scope of routine clinical care.
Management information
Registered date
| 2026 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069649
