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Recruitment status Completed
Unique ID issued by UMIN UMIN000011796
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email yasu_hr_j15@yahoo.co.jp

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013789


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