UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024775 |
|---|---|
| Receipt number | 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 | 2021/03/26 10:48:08 |
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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 | Keiji |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ichinomiya Nishi Hospital
Division name
Department of Neurology
Zip code
494-0001
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
TEL
+81-586-48-0077
k-yamaguchi@anzu.or.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ichinomiya Nishi Hospital
Division name
Department of Neurology
Zip code
494-0001
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
TEL
+81-586-48-0077
Homepage URL
k-yamaguchi@anzu.or.jp
Sponsor or person
Institute
Ichinomiya Nishi Hospital
Department of Neurology
Institute
Department
Personal name
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
Ichinomiya Nishi Hospital
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
Tel
0586-48-0077
matsubara@anzu.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
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
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028480
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