UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062927 |
|---|---|
| Receipt number | R000072051 |
| Scientific Title | Comparison of Lower Limb Joint Angles and Muscle Activity During Gait Based on Differences in Plantarflexion Resistance of Ankle-Foot Orthoses |
| Date of disclosure of the study information | 2026/10/09 |
| Last modified on | 2026/10/09 13:07:32 |
* 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
Comparison of Lower Limb Joint Angles and Muscle Activity During Gait Based on Differences in Plantarflexion Resistance of Ankle-Foot Orthoses
Acronym
Comparison of Lower Limb Joint Angles and Muscle Activity During Gait Based on Differences in Plantarflexion Resistance of Ankle-Foot Orthoses
Scientific Title
Comparison of Lower Limb Joint Angles and Muscle Activity During Gait Based on Differences in Plantarflexion Resistance of Ankle-Foot Orthoses
Scientific Title:Acronym
Comparison of Lower Limb Joint Angles and Muscle Activity During Gait Based on Differences in Plantarflexion Resistance of Ankle-Foot Orthoses
Region
| Japan |
Condition
Condition
Post-stroke hemiplegia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares lower-limb joint angles and muscle activity during walking in individuals with hemiplegia, using ankle-foot orthoses with varying degrees of plantarflexion resistance, to verify whether the devices possess a practical mechanism for adjusting plantarflexion resistance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle plantarflexion and dorsiflexion angles; electromyography of the tibialis anterior and soleus muscles.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Ankle-foot orthosis with plantarflexion control
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients presenting with hemiplegia
Key exclusion criteria
Individuals who have difficulty walking even with proximal supervision by a physical therapist; individuals who have difficulty understanding verbal instructions due to impaired consciousness or aphasia; and individuals exhibiting marked limitation of knee extension or ankle dorsiflexion.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Murayama |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation Department of Prosthetics and Orthotics for Independent Living Support
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4725
minoru-murayama@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Murayama |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation Department of Prosthetics and Orthotics for Independent Living Support
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4725
Homepage URL
minoru-murayama@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4725
minoru-murayama@nuhw.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 | 10 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000072051
