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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028527
Receipt No. R000032648
Scientific Title Effects of gait rehabilitation with Hybrid Assistive Limb in Stroke patients
Date of disclosure of the study information 2017/08/03
Last modified on 2017/08/03

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Basic information
Public title Effects of gait rehabilitation with Hybrid Assistive Limb in Stroke patients
Acronym Effects of gait rehabilitation with HAL in Stroke patients
Scientific Title Effects of gait rehabilitation with Hybrid Assistive Limb in Stroke patients
Scientific Title:Acronym Effects of gait rehabilitation with HAL in Stroke patients
Region
Japan

Condition
Condition Post-stroke patients
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of gait rehabilitation with HAL in stroke
patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Ambulation Category

Outcome measures are evaluate to prior to training, after training, and follow-up period.
Key secondary outcomes Fugl-Meyer Assessment of the lower extremity, muscle strength, gait speed, gait capacity, TUG, SF-8, adverse event.

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 Gait rehabilitation with HAL 3 times a week with a total of 12 or 18 HAL program sessions.

One session is 20 minutes.
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
100 years-old >
Gender Male and Female
Key inclusion criteria 1) Subjects with hemiparesis due to unilateral cerebral infarction or intra cerebral hemorrhage.
2) Within 6 months after stroke onset.
3) Subject with a score of from 0 to 3 on the Functional Ambulation Category.
Key exclusion criteria 1) Subjects could not put on the electrode surface of skin due to skin disease.
2) Subjects with size limitations for the robot suit HAL.
3) Subjects could not conventional gait treatment due to serious cardiopulmonary dysfunction.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisako Yanagi
Organization University of Tukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan.
TEL 029-853-3496
Email hyanagi@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Watanabe
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.
TEL 029-853-1131
Homepage URL
Email s1430398@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
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 08 Month 03 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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 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 08 Month 03 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032648

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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