UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060030 |
|---|---|
| Receipt number | R000067908 |
| Scientific Title | Effects of Gait Training Using knee ankle foot orthosis with Knee Extension Assist Mechanisms on Muscle Activity in the Paretic Rectus Femoris Muscle in Subacute Stroke Hemiplegic Patients. |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/09 17:29:19 |
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Basic information
Public title
Effects of Gait Training Using knee ankle foot orthosis with Knee Extension Assist Mechanisms on Muscle Activity in the Paretic Rectus Femoris Muscle in Subacute Stroke Hemiplegic Patients.
Acronym
Effects of Gait Training Using knee ankle foot orthosis with Knee Extension Assist Mechanisms on Muscle Activity in the Paretic Rectus Femoris Muscle in Subacute Stroke Hemiplegic Patients.
Scientific Title
Effects of Gait Training Using knee ankle foot orthosis with Knee Extension Assist Mechanisms on Muscle Activity in the Paretic Rectus Femoris Muscle in Subacute Stroke Hemiplegic Patients.
Scientific Title:Acronym
Effects of Gait Training Using knee ankle foot orthosis with Knee Extension Assist Mechanisms on Muscle Activity in the Paretic Rectus Femoris Muscle in Subacute Stroke Hemiplegic Patients.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the changes in muscle activity of the paretic lower limb that result from one month of walking practice using a knee-ankle-foot orthosis (KAFO) with a knee extension assist mechanism in stroke patients with hemiplegia presenting with severe gait impairment in the subacute phase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle activity ratio during the loading response phase of the paretic rectus femoris muscle (one month after initial measurement (1M))
Key secondary outcomes
Muscle activity ratio of the paretic side rectus femoris during the single-leg stance phase (1 month after initial measurement (1M))
Muscle activity ratio of the paretic side tibialis anterior during the load response phase and single-leg stance phase (1 month after initial measurement (1M))
Lower limb Brunnstrom Recovery Stage (BRS) scores at admission, initial assessment, 1M, and discharge
Functional Ambulation Categories (FAC) scores at admission, baseline, 1M, and discharge
Ambulation Independence Measure (AIM) scores at admission, baseline, 1M, and discharge
Motor Functional Independence Measure (Motor FIM) scores at admission, baseline, 1M, and discharge
Cognitive Functional Independence Measure (Cognitive FIM) scores at admission, baseline, 1M, and discharge
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hemiplegia due to stroke admitted to our hospital's recovery-phase rehabilitation ward between August 2023 and February 2025.
Patients for whom cerebrovascular disease rehabilitation fees were billed.
Patients for whom a custom-made long leg orthosis (KAFO) was fabricated with the goal of improving walking ability.
Patients for whom the necessity of KAFO was discussed by a team including a rehabilitation specialist during an orthotic consultation.
Patients for whom lower limb muscle activity (EMG) data could be obtained at baseline and 1 month (1M) post-intervention.
Patients who provided consent to participate in this study (consent for participation in the study or use of existing data, as this is a retrospective 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 who were not experiencing their first stroke.
Individuals with missing values in the data required for analysis (muscle activity data or FIM scores).
Individuals who withdrew during the study period due to poor health or other reasons.
Target sample size
20
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
830-0038
Address
914 Nishimachi, Kurume City, Fukuoka Prefecture
TEL
0942-32-4565
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
830-0038
Address
914 Nishimachi, Kurume City, Fukuoka Prefecture
TEL
0942-32-4565
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
Name of secondary funder(s)
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
医療法人福岡桜十字 花畑病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
Results
Main Outcome Measure Results
Item Muscle activity ratio during the loading response phase of the paretic rectus femoris
Initial 156.61(SD 46.45) vs 1M 239.51(SD 112.92)
Conclusion The muscle activity ratio increased significantly,P=0.0104.
Results date posted
| 2025 | Year | 10 | Month | 11 | Day |
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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
This study is a retrospective observational study using medical record data. It included 13 stroke patients with hemiplegia who were hospitalized between August 2023 and February 2025 and received a knee-ankle-foot orthosis KAFO with an assisted knee extension mechanism. The observation period covered the entire duration from admission to discharge mean 163.5 days. Changes in the primary outcomes muscle activity of the paralyzed side rectus femoris muscle and functional independence measure FIM were explored before and after intensive walking training using the KAFO.
This study is a retrospective observational study and subject enrollment occurred prior to the protocol finalization date July 31 2023. Ethical approval was obtained on April 30 2024 after UMIN registration approval number SJF-20240430.
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067908
