UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020842 |
|---|---|
| Receipt number | R000023884 |
| Scientific Title | Gait walking training using the Robot Suit HAL for incomplete spinal cord injury patients |
| Date of disclosure of the study information | 2016/02/02 |
| Last modified on | 2023/08/24 13:24:20 |
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Basic information
Public title
Gait walking training using the Robot Suit HAL for incomplete spinal cord injury patients
Acronym
HAL gait training
Scientific Title
Gait walking training using the Robot Suit HAL for incomplete spinal cord injury patients
Scientific Title:Acronym
HAL gait training
Region
| Japan |
Condition
Condition
Incomplete Spinal Cord Injury Patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility and efficacy of HAL as a rehabilitation method in regaining gait ability for spinal cord injury patients with incomplete paralysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
6 minutes walk, without Robot Suit HAL
Before training
During training every 1 month
After training
Key secondary outcomes
Walking Index for Spinal Cord Injury (WISCI) version II
Berg balance scale(BBS)
Function Independence Measure(FIM)
10m walk
Isometric knee extension muscular strength level
Average stride length
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Gait walking training using the Robot Suit HAL
2-days per week, up to 6 months
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Incomplete Spinal Cord Injury patients
2.Patients classified as C or D on the ASIA impairment scale
3.The patient that an assistance walk is possible using a walk aid or lower limbs harness
4.Patients can consent by a document. If the handwriting is difficult due to Nerve paralysis, it is assumed to obtain a document consent from ghost-writing user.
5.Patients aged between 18 and 65 years at the acquisition of informed consent
Key exclusion criteria
1.Patient whom the bioelectric potential cannot detect
2.Other patients who were judged to be ineligible by the investigators or physiotherapist
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Chin |
Organization
1.The Hyogo Institute of Assistive Technology
2.Hyogo Prefectural Central Rehabilitation Hospital
Division name
1.Director2.Physical Rehabilitation
Zip code
6512181
Address
Akebonocho 1070 Kobe Nishi-ku, Hyogo, 651-2181
TEL
078-927-2727
chin@assistech.hwc.or.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ishii |
Organization
The Hyogo Institute of Assistive Technology
Division name
Robot Rehabilitation Center Section
Zip code
6512181
Address
Akebonocho 1070 Kobe Nishi-ku, Hyogo, 651-2181
TEL
078-927-2727
Homepage URL
info00@assistech.hwc.or.jp
Sponsor or person
Institute
The Hyogo Institute of Assistive Technology
Institute
Department
Personal name
Funding Source
Organization
The Hyogo Institute of Assistive Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Intelligent Interaction Technologies, University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Prefectural Central Rehabilitation Hospital
Address
Akebonocho 1070 Kobe Nishi-ku, Hyogo, 651-2181
Tel
078-927-2727
n_nagura@hwc.or.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
| 2016 | Year | 02 | Month | 02 | 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
| 2010 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023884
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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