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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025591
Receipt No. R000029379
Scientific Title Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Date of disclosure of the study information 2017/01/13
Last modified on 2018/04/06

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Basic information
Public title Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Acronym Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Scientific Title Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Scientific Title:Acronym Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Region
Japan

Condition
Condition stroke, spinal cord injury, knee/hip joint injury
Classification by specialty
Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate the safety and efficacy of HAL in rehabilitation medicine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of myopotential signals of each lower limb muscle
Key secondary outcomes 1)video image
2)range of motion of the joints in the lower extremities
3)muscle strength of the lower extremities
4)cardiopulmonary function (heart rate, blood pressure, rating of perceived exertion(Borg Scale))
5)satisfaction with the assistance in mobility provided by HAL

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 to walk 10m wearing HAL at the first day and the last day of rehabilitation
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

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who are diagnosed as stroke, spinal cord injury, or knee/hip joint injury

Subjects must satisfy the following conditions for inclusion:
1.who have difficulty walking and cannot walk independently
2.who are fully informed and understand about this study, and then provide the written voluntary consent to participation
Key exclusion criteria The following patients will be excluded:
1.who are under 20 years old
2.who are determined to have difficulty understanding due to dementia ,higher brain dysfunction and the other reason
3.who have poorly controlled hypertension, heart failure, osteoporosis, and the other disease
4.who are in life-threatening medical condition, and are forbidden exercise by a doctor
5.who are determined as unsuitable subjects by investigators for various other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsuo Chosa
Organization University of Miyazaki Hospital
Division name Rehabilitation unit and Orthopaedic Surgery
Zip code
Address 5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL 0985-85-0986
Email seikei@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Etsuo Chosa
Organization University of Miyazaki Hospital
Division name Rehabilitation unit and Orthopaedic Surgery
Zip code
Address 5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL 0985-85-0986
Homepage URL
Email seikei@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki Hospital
Institute
Department

Funding Source
Organization None
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
2017 Year 01 Month 13 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 No longer recruiting
Date of protocol fixation
2013 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 14 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
2017 Year 01 Month 10 Day
Last modified on
2018 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029379

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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