UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020842
Receipt No. 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 2021/08/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email t-chin@pure.ne.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
Email info00@assistech.hwc.or.jp

Sponsor
Institute The Hyogo Institute of Assistive Technology
Institute
Department

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
Email k_ikawa@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
2021 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023884

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.