UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012879 |
|---|---|
| Receipt number | R000015036 |
| Scientific Title | the effects of Stride Management Assist Device for patients after stroke in sub-acute phase. |
| Date of disclosure of the study information | 2014/01/20 |
| Last modified on | 2016/02/04 18:19:59 |
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Basic information
Public title
the effects of Stride Management Assist Device for patients after stroke in sub-acute phase.
Acronym
the effects of Stride Management Assist Device
Scientific Title
the effects of Stride Management Assist Device for patients after stroke in sub-acute phase.
Scientific Title:Acronym
the effects of Stride Management Assist Device
Region
| Japan |
Condition
Condition
patients after stroke in sub-acute phase
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effects of robot -assisted gait training with new device named Stride Management Assist Device (SMAD) on kinematic, kinetic gait parameters, muscle activities during walking, and motor function in individuals after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Gait Analysis: peak joint angles and joint moments during walking.
Gait EMG analysis: muscle activity at Tibialis anterior, Gastrocmemius , and Soleus.
Key secondary outcomes
Brunnstrom stage(BRS), Barthal Index(BI), Functional Ambulation Category(FAC), Modified Ashworth Scale(MAS), 10m walk test(TWT), Timed Up and Go(TUG), Muscle strength of hip knee ankle joints, Short Form of the Berg Balance Scale(SFBBS), Functional Reach Test(FRT), Activities specific Balance Confidence scale(ABC), and Trunk Impairment Scale(TIS).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
group A received regular physiotherapy for 20 minutes and gait training with SMAD for 20 minutes each workday 5 times a week for 4 weeks. Then, without wash-out phase, this group eceived regular physiotherapy for 20 minutes and gait training without SMAD for 20 minutes each workday 5 times a week for 4 weeks.
Interventions/Control_2
group B received regular physiotherapy for 20 minutes and gait training without SMAD for 20 minutes each workday 5 times a week for 4 weeks. Then, without wash-out phase, this group eceived regular physiotherapy for 20 minutes and gait training with SMAD for 20 minutes each workday 5 times a week for 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged more than 20 years old and who are allowed to participate the study by the attending physician.
Time since stroke onset <3 months
Ability to ambulate 10meters independently without brace
Cognitive ability to understand the explanation of the study and to follow the training instructions.
Key exclusion criteria
Bilateral stroke or stroke of the brainstem.
Severe cardiac or heart disease to limit the activity.
Severe orthopedic disease limiting walking in the spine or lower extremities.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
Address
53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3918
ohata.koji.7n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
Address
53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3918
Homepage URL
ohata.koji.7n@kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate school of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Honda R&D Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
湯布院厚生年金病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015036
