UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034581 |
|---|---|
| Receipt number | R000039219 |
| Scientific Title | Clinical study to verify the effectiveness of a knee ankle foot orthosis with MR fluid in the knee joint |
| Date of disclosure of the study information | 2018/10/20 |
| Last modified on | 2023/12/08 17:36:08 |
* 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 study to verify the effectiveness of a knee ankle foot orthosis with MR fluid in the knee joint
Acronym
Effectiveness of MR-KAFO
Scientific Title
Clinical study to verify the effectiveness of a knee ankle foot orthosis with MR fluid in the knee joint
Scientific Title:Acronym
Effectiveness of MR-KAFO
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to verify whether the knee ankle foot orthosis (KAFO) with (magneto-rheological (MR) fluid in the knee joint (MR-KAFO) would be more useful than the conventional KAFO.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation items are neurological findings, severity of paralysis (Brunnstrome stage, SIAS), measurement of range of motion in the joints, manual muscle testing in the sound side, activities of daily living (FIM), walking evaluation. In addition, we listen to opinions on whether physical therapists are easy to use in their gait training.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
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 MR-KAFO is used for gait training of patients with severe hemiplegia due to acute onset stroke.
Interventions/Control_2
Medical histories are investigated for patients who have performed gait training using a conventional KAFO.
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
| 41 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with acute first stroke, who receive rehabilitation training from the earliest onset
2) Patients with severe hemiplegia, who can not walk with the AFO
Key exclusion criteria
1) Patients who have no adaptation for gait training due to prolonged consciousness disturbance
2) Patients who do not understand the contents of gait training at all or refuse to train, because of severe aphasia or higher brain dysfunction.
3) Patients who are strongly tired and can not perform the gait training, because of complications such as heart diseases and kidney diseases.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Hanayama |
Organization
Kawasaki Medical School
Division name
Rehabilitation Medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki-City, Okayama
TEL
0864621111
hanayama@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Hanayama |
Organization
Kawasaki Medical School
Division name
Rehabilitation Medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki-City, Okayama
TEL
0864621111
Homepage URL
hanayama@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki University of Medical Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki-City, Okayama
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
10
Results
MR-KAFO is a brace which can adjust the braking force of the knee joint according to the gait cycle. We use a MR-KAFO for some stroke patients with hemiplegia. As a result, it was possible to train for them to walk with a gait closer to normal gait than with conventional ring-lock knee joint KAFO or AFO (Ankle Foot Orthosis). MR-KAFO may be indicated for a relatively long period of time in stroke patients with severe to moderate paralysis.
Results date posted
| 2023 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age: mean 50.0 (SD 21.9)
Sex:1 women, 9 men
Disease: 5 cerebral infarction, 5 cerebral hemorrhage
Participant flow
10 participants agreed. There were no exclusions or dropouts.
Adverse events
None
Outcome measures
Number of days to change from a Knee Ankle Foot Orthosis (KAFO) to an Ankle Foot Orthosis (AFO)
Ambulation
FIM walk (FIM; Functional Independent Measurement)
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is terminated because we decided that we needed to significantly change the protocol.
Management information
Registered date
| 2018 | Year | 10 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
