UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060939 |
|---|---|
| Receipt number | R000064694 |
| Scientific Title | Effectiveness of Knee Ankle Foot Orthosis for Acute Stroke Patients |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/15 14:37:32 |
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Basic information
Public title
Effectiveness of Knee Ankle Foot Orthosis for Acute Stroke Patients
Acronym
Effectiveness of Knee Ankle Foot Orthosis for Acute Stroke Patients
Scientific Title
Effectiveness of Knee Ankle Foot Orthosis for Acute Stroke Patients
Scientific Title:Acronym
Effectiveness of Knee Ankle Foot Orthosis for Acute Stroke Patients
Region
| Japan |
Condition
Condition
Acute Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine how muscle activity during gait is altered by practicing gait in an antegrade gait with KAFO compared to AFO in patients with acute stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements will be taken at baseline before the start of the program and after 3 days of walking practice with each orthosis. The method of measurement is to measure muscle activity during walking with a surface electromyograph. Electrodes will be attached to the subject in order to use the surface electromyograph. The electrodes will be affixed at four locations recommended by SENIAM: rectus femoris, semitendinosus muscle, tibialis anterior muscle, and lateral head of gastrocnemius muscle. AFOs will be used for measurements, and the foot joints will be hydraulic plantar flexion braking foot joints, handrail grasping, and unassisted. Measurements will be taken after each walking exercise of AFO and KAFO. The KAFO group will be measured after the KAFO (3 days) to confirm the load and muscle activity during walking with the KAFO, using both AFO and KAFO.
Key secondary outcomes
The amount of load is measured by a load meter attached to the KAFO. The KAFO group will be measured at both AFO and KAFO after the completion of KAFO (3 days) to confirm the amount of load during walking using KAFO.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
KAFO group is AFO (3 days) to KAFO (3 days) to AFO (3 days)
Interventions/Control_2
AFO group is AFO (3 days) to AFO (3 days) to AFO (3 days)
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
| 18 | years-old | <= |
Age-upper limit
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Lower limb Brunnstrom recovery stage III-V, AFO, able to walk with watchful waiting in the parallel bars
Key exclusion criteria
Subarachnoid hemorrhage, recurrent cases, those with dementia or higher brain dysfunction that precludes consent for the study, those with other neurological diseases, and those with independent walking.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Takahashi |
Organization
International University of Health and Welfare, Graduate School
Division name
Welfare Assistive Technology
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3874
sumiko-y@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Metropolitan Ebara Hospital
Division name
Department of Rehabilitation
Zip code
14-0065
Address
4-5-10 Higashi-Yukigaya, Ota-ku, Tokyo
TEL
080-3439-7028
Homepage URL
23s3032@g.iuhw.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Ebara Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, International University of Health and Welfare, Tokyo Akasaka Area
Address
Office, 4F, Building E, Tokyo Akasaka Campus, 4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
rinri-tky@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 15 | Day |
Last modified on
| 2026 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064694
