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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024775
Receipt No. R000028480
Scientific Title A safety study of HAL therapy for gait disturbance due to acute stroke
Date of disclosure of the study information 2016/11/09
Last modified on 2018/11/12

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Basic information
Public title A safety study of HAL therapy for gait disturbance due to acute stroke
Acronym Safety of HAL therapy for acute stroke
Scientific Title A safety study of HAL therapy for gait disturbance due to acute stroke
Scientific Title:Acronym Safety of HAL therapy for acute stroke
Region
Japan

Condition
Condition Acute stroke (Cerebral infarction, Cerebral hemorrhage)
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the safety of the acute phase intervation of HAL therapy for the acute stroke patients with gait disturbance due to hemiplegia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Adverse event(accident during HAL therapy,stroke recurrence,complication of severe systemic disease)
Key secondary outcomes Body Impairment Outcome Measures
Brunnstrom stage (BRs)
12grade hemiplesia functional test
Fugl-meyer assessment
6m-Gait speed,Stride,Cadence,Gait distance for 6 min
NIHSS
Activity/Disability Outcome Measures
modified Rankin Scale (mRS)
Barthel Index (BI)
Functional Independence Measure (FIM)
Others
MMSE
Medical Outcomes Study Short Form 36(SF36)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Gait training utilizing HAL(hybrid assistive limb, HAL-ML05) for 40 minutes and conventional physical therapy for 20 minutes per day, 5 times a week, combined with conventional physical therapy for 60 minutes per day, 2 times a week, for a session, with a total of 4 sessions (4 weeks).
Interventions/Control_2 Gait training utilizing HAL for 40 minutes and conventional physical therapy for 20 minutes per day, 3 times a week, combined with conventional physical therapy for 60 minutes per day, 4 times a week, for a session, with a total of 4 sessions (4 weeks).
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1)Age:20-89 years old
2)Confirmation of acute ischemic or hemorrhagic stroke lesion on MRI/CT, associated with hemiplegia
3)Time since stroke onset within 7-14 days.
4)Functional Ambulation Category (FAC) score of 0-2
5)Patient can ensure more than 4 weeks from intervention initiation.
6) Patient can consent by a document.

Key exclusion criteria 1)Patient who cannot be suitable for HAL. 2)Patient who cannot walk with HAL.
3)Disturbance of consciousness
4)MMSE score is less than 23.
5)Pre-stroke mRS score is above 2.
6)Severe cardio-pulmonary dysfunction(
NYHA; stage III or IV)
7)Patient treated with intravenous drip or oxygen inhalation.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Yamaguchi
Organization Ichinomiya Nishi Hospital
Division name Department of Neurology
Zip code
Address 1, Kaimei-hira, Ichinomiya-city, Aichi
TEL +81-586-48-0077
Email k-yamaguchi@anzu.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiji Yamaguchi
Organization Ichinomiya Nishi Hospital
Division name Department of Neurology
Zip code
Address 1, Kaimei-hira, Ichinomiya-city, Aichi
TEL +81-586-48-0077
Homepage URL
Email k-yamaguchi@anzu.or.jp

Sponsor
Institute Ichinomiya Nishi Hospital
Department of Neurology
Institute
Department

Funding Source
Organization Ichinomiya Nishi Hospital
Department of Neurology
Organization
Division
Category of Funding Organization Other
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 一宮西病院

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 09 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
No serious adverse events was observed during the protocol both in the three days a week HAL therapy group and the five days a week HAL therapy group. One case in the three days a week HAL therapy group discontinued the protocol because she disliked the therapy.All the other cases completed the four weeks protocol.
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 Completed
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 09 Day
Last follow-up date
2017 Year 12 Month 15 Day
Date of closure to data entry
2018 Year 01 Month 31 Day
Date trial data considered complete
2018 Year 02 Month 28 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028480

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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