UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011796 |
|---|---|
| Receipt number | R000013789 |
| Scientific Title | The effect of a hinged knee brace with flexion support system on genu recurvatum in patients with stroke. |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2014/12/15 22:57:26 |
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Basic information
Public title
The effect of a hinged knee brace with flexion support system on genu recurvatum in patients with stroke.
Acronym
The effect of a hinged knee brace with flexion support system on genu recurvatum in patients with stroke.
Scientific Title
The effect of a hinged knee brace with flexion support system on genu recurvatum in patients with stroke.
Scientific Title:Acronym
The effect of a hinged knee brace with flexion support system on genu recurvatum 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 investigate the effect of a hinged knee brace with flexion support system on genu recurvatum in stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
angular acceleration of knee joint in stance phase and other kinematic data obtained from the motion analysis
Key secondary outcomes
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
knee brace
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) stroke patients with genu recurvatum in paralyzed side during stance phase of walking.
2) Functional Ambulation Categories 3-5.
3) patients who can walk on a treadmill with a harness support.
4) consent to participate in the study.
Key exclusion criteria
1) disturbance of consciousness, movement disorder other than hemiplegia.
2) difficult to understand the tasks due to cognitive disturbances.
3) difficult to communicate verbally.
4) contraindication to exercises due to severe heart, lung and other diseases.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Tani |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Rehabilitation department
Zip code
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9010
yasu_hr_j15@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Tani |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Rehabilitation department
Zip code
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9010
Homepage URL
yasu_hr_j15@yahoo.co.jp
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University, Graduate School of Medicine.
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
東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 18 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 25 | 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
| 2013 | Year | 09 | Month | 18 | Day |
Last modified on
| 2014 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013789
| 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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