UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036464 |
|---|---|
| Receipt number | R000041442 |
| Scientific Title | Kinematic study of the genu recurvatum during gait in patients with stroke |
| Date of disclosure of the study information | 2019/04/20 |
| Last modified on | 2019/04/10 13:28:36 |
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Basic information
Public title
Kinematic study of the knee joint during gait in patients with stroke
Acronym
Kinematic study of the knee joint during gait in patients with stroke
Scientific Title
Kinematic study of the genu recurvatum during gait in patients with stroke
Scientific Title:Acronym
Kinematic study of the genu recurvatum during gait in patients with stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To classification genu recurvatum in patients with stroke based on the kinematic evaluation of gait and investigate the relationship between kinematic evaluation and clinical assessments.
Basic objectives2
Others
Basic objectives -Others
Cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait analysis (three-dimensional motion analysis and surface electromyogram)
Key secondary outcomes
Video analysis of gait, Fugl-Meyer Assessment, Stroke Impairment Assessment Set, Modified Ashworth Scale, muscle strength assessment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) First-time stroke patients
2) 90 to 120 days after onset
3) able to walk independently without assistive tool / brace
4) MMSE-J >= 23 points, and those who can understand the content of the research and gained consent
Key exclusion criteria
1) Those who newly started medication for spasticity during the evaluation time (eg. antispasmodic oral administration, botulinum toxin injection)
2) those with severe orthopedic disease affecting gait function
3) Those with serious cardiac disease: unstable angina, myocardial infarction shortly after symptom onset, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, serious aortic stenosis, active myocarditis, endocarditis, etc.
4) Those with severe lower limb joint contracture affecting gait
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Yasui |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1, Yatsu, Narashino-shi, Chiba
TEL
047-453-9000
t10.a.31k.y917@gmail.com
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Yasui |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1, Yatsu, Narashino-shi, Chiba
TEL
047-453-9000
Homepage URL
t10.a.31k.y917@gmail.com
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Rehabilitation Hospital
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
Tokyo Bay Rehabilitation Hospital
Address
4-1-1, Yatsu, Narashino-shi, Chiba
Tel
047-453-9000
shinsakai@wanreha.net
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
| 2019 | Year | 04 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Classification of gait pattern in patients with genu recurvatum based on kinematic analysis / The comparison of clinical factors between patients with and without genu recurvatum.
Management information
Registered date
| 2019 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041442
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
