UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062432 |
|---|---|
| Receipt number | R000068974 |
| Scientific Title | Verification of the Efficacy of Orthobot-Assisted Gait Training in the Transition from KAFO to AFO for Stroke Hemiplegia Patients |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/08/01 08:06:38 |
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Basic information
Public title
Verification of the Efficacy of Orthobot-Assisted Gait Training in the Transition from KAFO to AFO for Stroke Hemiplegia Patients
Acronym
Verification of the Efficacy of Orthobot-Assisted Gait Training in the Transition from KAFO to AFO for Stroke Hemiplegia Patients
Scientific Title
Verification of the Efficacy of Orthobot-Assisted Gait Training in the Transition from KAFO to AFO for Stroke Hemiplegia Patients
Scientific Title:Acronym
Verification of the Efficacy of Orthobot-Assisted Gait Training in the Transition from KAFO to AFO for Stroke Hemiplegia Patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During gait training for stroke patients with hemiplegia, the quality of assistance provided during knee joint lock-off in the transition phase from a knee-ankle-foot orthosis to an ankle-foot orthosis tends to vary depending on the therapist's years of experience. The gait-learning support robot Orthobot, developed by Suncall Corporation, enables safe gait training by automatically controlling knee flexion and extension. However, no cases have been identified to date combining the Orthobot with a plastic AFO-type KAFO. The objective is therefore to verify whether attaching the Orthobot to a plastic AFO-type KAFO and utilizing it for gait learning during knee joint lock-off can resolve the aforementioned issue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity ratio during the loading response phase of the paretic rectus femoris muscle
Key secondary outcomes
Muscle activity ratio of the paretic rectus femoris during the single-leg support phase
Muscle activity ratio of the paretic tibialis anterior during the loading response phase and single-leg support phase
10m walking speed
Number of steps during 10m walking
Lower limb Brunnstrom Recovery Stage (BRS) score
Functional Ambulation Categories (FAC) score
Ambulation Independence Measure (AIM) score
Motor Functional Independence Measure (Motor FIM) score
Cognitive Functional Independence Measure (Cognitive FIM) score
(The following are exploratory outcomes added after the study had commenced, upon introduction of the motion analysis system and with the approval of the institutional ethics committee)
Mean trunk angle during the gait cycle
Mean knee joint angle during the loading response phase
Peak knee flexion angle during the swing phase
Base
Study type
Interventional
Study design
Basic design
n-of-1
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional physical therapy. The participant performs 40 minutes of gait training per day for 5 days using a custom-made knee-ankle-foot orthosis with a spring-assisted extension (SPEX) knee joint in the unlocked condition, without the robotic device.This study employs an A-B-A design, in which Intervention 1, Intervention 2, and Intervention 1 are administered in this order for 5 days each.
Interventions/Control_2
The Orthobot is mounted onto the same SPEX-KAFO using a universal attachment and used in the "stumble prevention assist" mode for 40 minutes of gait training per day for 5 days. The Orthobot is not an approved medical device under the Japanese Pharmaceuticals and Medical Devices Act; it is certified under ISO 13482 as a personal care robot. This study employs an A-B-A design, in which Intervention 1, Intervention 2, and Intervention 1 are administered in this order for 5 days each.
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
Patients with hemiplegia following stroke admitted to our hospital's convalescent rehabilitation ward.
Patients prescribed rehabilitation for cerebrovascular disease or similar conditions.
Patients for whom a customized knee-ankle-foot orthosis (KAFO) with a spring-assisted extension (SPEX) knee joint was fabricated to improve walking ability.
Patients whose orthosis allowed the Orthobot to be mounted using the universal attachment.
Patients for whom the necessity of the KAFO was discussed by a team including a rehabilitation specialist during an orthotic consultation.
Patients for whom lower limb muscle activity (electromyography) data could be obtained.
Patients who provided informed consent to participate in this study.
Key exclusion criteria
Individuals for whom the purpose of KAFO fabrication was not to acquire walking ability, but rather to improve durability.
Individuals prescribed bilateral KAFOs.
Individuals with significant orthopedic conditions (as these may affect walking ability).
Individuals whose stroke was not a first-ever event.
(The following are criteria for exclusion from analysis or withdrawal)
Individuals with missing values in the data required for analysis (muscle activity data or FIM scores).
Individuals who withdrew during the study period owing to poor physical condition or other reasons.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka Sakurajuji Medical Corporation Hanabatake Hospital / Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Division name
Rehabilitation Department
Zip code
838-0214
Address
914 Nishimachi, Kurume City, Fukuoka Prefecture
TEL
09092057660
mugonjikkou@yahoo.co.jp
Public contact
Name of contact person
| 1st name | daichi |
| Middle name | |
| Last name | yoshida |
Organization
Fukuoka Sakurajuji Medical Corporation Hanabatake Hospital
Division name
Rehabilitation Department
Zip code
838-0214
Address
914 Nishimachi, Kurume City, Fukuoka Prefecture
TEL
09092057660
Homepage URL
mugonjikkou@yahoo.co.jp
Sponsor or person
Institute
Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Institute
Department
Personal name
daichi yoshida
Funding Source
Organization
Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fingall Link Co., Ltd.
Name of secondary funder(s)
Fingall Link Co., Ltd.
IRB Contact (For public release)
Organization
Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Address
5-11 Watanabe-dori 3-chome, Chuo Ward, Fukuoka City
Tel
092-791-1100
mugonjikkou@yahoo.co.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
福岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
2
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2026 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068974
