UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028527 |
|---|---|
| Receipt number | 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 19:04:14 |
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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
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
s1430398@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032648
