UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032094 |
|---|---|
| Receipt number | R000036618 |
| Scientific Title | Clinical assessment of a knee ankle foot orthosis with braking knee joint |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2022/10/14 15:11:53 |
* 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
Clinical assessment of a knee ankle foot orthosis with braking knee joint
Acronym
Clinical assessment of a knee ankle foot orshosis with braking knee joint
Scientific Title
Clinical assessment of a knee ankle foot orthosis with braking knee joint
Scientific Title:Acronym
Clinical assessment of a knee ankle foot orshosis with braking knee joint
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know the effect of the Knee Ankle Foot Orthosis with mechanical knee joint containing electro attractive material on the gait of stroke patients in recovery phase
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Trunk movement during gait before and after gait training using the orthosis
Key secondary outcomes
Gait speed and kinematic and kinetic gait parameters before and after gait trining using the orthosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Gait training using a Knee Ankle Foot Orthosis with a mechanical knee joint using electro attractive material
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients in revovery phase, taking rehabilitation program at hoipitals, having gait trainig by physiotherapists using Knee Ankle Foot Orshoses
Key exclusion criteria
Difficulty to understand oral instruction
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Sumiko |
| Middle name | |
| Last name | Yamamoto |
Organization
International University of Health and Welfare
Division name
Graduate school
Zip code
107-8402
Address
4-1-26, Akasaka, Minato-ku, Tokyo, Japan
TEL
+81-3-5574-3874
sumiko-y@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sumiko |
| Middle name | |
| Last name | Yamamoto |
Organization
International University of Health and Welfare
Division name
Graduate school
Zip code
107-8402
Address
4-1-26, Akasaka, Minato-ku, Tokyo, Japan
TEL
+81-3-5574-3874
Homepage URL
sumiko-y@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
The Fujikura Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Senri Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health & Welfare
Address
4-1-26, Akasaka, MInato-ku, Tokyo, Japan ,
Tel
09046630750
sumiko-y@iuhw.ac.jp
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
千里リハビリテーション病院（大阪府）、海老名総合病院（神奈川県）、中伊豆リハビリテーションセンター（静岡県）、ねりま健育会病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036618
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
