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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023484
Receipt No. R000027052
Scientific Title The effects of Hybrid Assistive Limb (HAL) in the patients with spinal cord injury.
Date of disclosure of the study information 2016/08/05
Last modified on 2016/08/04

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Basic information
Public title The effects of Hybrid Assistive Limb (HAL) in the patients with spinal cord injury.
Acronym The effects of HAL in the patients with spinal cord injury.
Scientific Title The effects of Hybrid Assistive Limb (HAL) in the patients with spinal cord injury.
Scientific Title:Acronym The effects of HAL in the patients with spinal cord injury.
Region
Japan

Condition
Condition patients with spinal cord injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of HAL on gait ability in patients with spinal cord injury.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10-m walk test , 6 minutes walk test
Key secondary outcomes TUG, gait analysis, accelerometer, BBS, Gait Judge System, surface EMG, fNIRS, ADL (FIM), Stroke impact Scale, questionnaire

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 gait exercise with HAL
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) patients with spinal cord injury
2) stable medical condition, and duration from the onset of SCI is over 1 month
3) ability to walk indoor
4) age is over 20 years
5) patients who agree to participate in this study
Key exclusion criteria 1) patients who could not resord the EMG signal
2) severe higher cortical dysfunction, dementia, loss of consciousness
3) pacemaker implantation, or severe cardiopulmonary disease
4) severe restriction of ROM
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Email shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Homepage URL
Email shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization N/A
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
Address
Tel
Email

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 08 Month 05 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
Date of protocol fixation
2016 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2016 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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