UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022782 |
|---|---|
| Receipt number | R000026254 |
| Scientific Title | Efficacy validation of equinovarus suppression ankle foot orthosis for stroke hemiparesis |
| Date of disclosure of the study information | 2016/06/19 |
| Last modified on | 2016/06/29 16:36:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy validation of equinovarus suppression ankle foot orthosis for stroke hemiparesis
Acronym
Efficacy validation of equinovarus suppression ankle foot orthosis for stroke hemiparesis
Scientific Title
Efficacy validation of equinovarus suppression ankle foot orthosis for stroke hemiparesis
Scientific Title:Acronym
Efficacy validation of equinovarus suppression ankle foot orthosis for stroke hemiparesis
Region
| Japan |
Condition
Condition
Equinovarus of stroke hemiplegia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To cure the equinovarus foot, we aimed development of the orthosis that can dorsiflexion and valgus by the tow of strings. This clinical trial is verification of the efficacy of this orthosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the transition of the position of the center of gravity at the time of walking by applying the orthosis to the patient. This clinical trial will be carried out for about 6 to 10 times in one month. The number of times of the clinical trials by the judgment of the practitioner is increased.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The patient carries out the four tasks shown below in clinical trial once.
The task is carried out all at random.
Task 1
Without the application of the orthosis
Carry out the 10m walking 5 times
Task 2
Apply a commercially available orthosis
Carry out the 10m walking 5 times
Task 3
Apply the RT orthosis of previous version
Carry out the 10m walking 5 times
Task 4
Apply this RT orthosis
Carry out the 10m walking 5 times
Interventions/Control_2
The patient is carried out the usual rehabilitation period of the clinical trials.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Able to walk in the Brunnstrom stage 3 or more
2. Having sufficient joint mobility (dorsiflexion 5[deg]~ plantar flexion 30[deg])
3. It does not have the anesthesia
4. Mini Mental State Examination: 23 points or more
5. Frontal Assessment Battery: 12 points or more
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
Address
Shinjuku-ku, Tokyo Waseda-cho, 27 Waseda University Green Computing System Institute
TEL
03-3203-4531
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
Address
Shinjuku-ku, Tokyo Waseda-cho, 27 Waseda University Green Computing System Institute
TEL
03-3203-4531
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
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
| 2016 | Year | 06 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | 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
| 2016 | Year | 06 | Month | 18 | Day |
Last modified on
| 2016 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026254
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
