UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062812 |
|---|---|
| Receipt number | R000071868 |
| Scientific Title | Effect of shoe lift height on oxygen consumption during walking with a knee-ankle-foot orthosis |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/03 19:29:04 |
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Basic information
Public title
Effects of shoe height on the opposite side on energy expenditure during walking with a leg brace
Acronym
Shoe height and energy expenditure during walking with a leg brace
Scientific Title
Effect of shoe lift height on oxygen consumption during walking with a knee-ankle-foot orthosis
Scientific Title:Acronym
Shoe lift height and oxygen consumption during KAFO walking
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of different contralateral shoe lift heights on oxygen consumption during walking with a knee-ankle-foot orthosis (KAFO) in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Oxygen consumption (VO2). VO2 will be measured using a respiratory gas analyzer during 6-minute treadmill walking under each condition, and the mean value from 3 to 6 minutes after the start of walking will be evaluated.
Key secondary outcomes
Carbon dioxide output (VCO2), heart rate (HR), respiratory rate (RR), minute ventilation (VE), tidal volume (TV), modified Borg Scale, center of mass, walking speed, step length, stride length, lateral circumduction of the lower limb during the swing phase of walking, pelvic lateral tilt in the frontal plane, and excessive vertical elevation of the trunk and pelvis will be evaluated. Respiratory gas-related variables will be measured during 6-minute treadmill walking under each condition, and the mean values from 3 to 6 minutes after the start of walking will be evaluated.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Walking without a knee-ankle-foot orthosis (KAFO) or shoe lift. For respiratory gas analysis, participants walk on a treadmill for 6 minutes at the predetermined comfortable walking speed. For three-dimensional motion analysis, participants walk along an approximately 6-m walkway at a comfortable walking speed.
Interventions/Control_2
Walking with a knee-ankle-foot orthosis (KAFO) and without a shoe lift on the contralateral side (0-cm condition). For respiratory gas analysis, participants walk on a treadmill for 6 minutes at the predetermined comfortable walking speed. For three-dimensional motion analysis, participants walk along an approximately 6-m walkway at a comfortable walking speed.
Interventions/Control_3
Walking with a knee-ankle-foot orthosis (KAFO) and a 1.0-cm shoe lift on the contralateral side. For respiratory gas analysis, participants walk on a treadmill for 6 minutes at the predetermined comfortable walking speed. For three-dimensional motion analysis, participants walk along an approximately 6-m walkway at a comfortable walking speed.
Interventions/Control_4
Walking with a knee-ankle-foot orthosis (KAFO) and a 2.0-cm shoe lift on the contralateral side. For respiratory gas analysis, participants walk on a treadmill for 6 minutes at the predetermined comfortable walking speed. For three-dimensional motion analysis, participants walk along an approximately 6-m walkway at a comfortable walking speed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults aged 18 years or older
2.Individuals who have no difficulty walking in daily life and are able to walk independently without assistive devices
3.Individuals without apparent orthopedic or neurological disorders of the lower limbs or trunk that may affect walking
4.Individuals who have received and understood a sufficient explanation of the purpose and procedures of the study and provided written informed consent
Key exclusion criteria
1.Individuals with a history of lower-limb fracture or surgery that may affect joint range of motion, muscle strength, or gait pattern
2.Individuals with brain or spinal cord disorders, peripheral neuropathy, balance disorders, or other conditions that may affect the safety or stability of walking
3.Individuals with hypertension, ischemic heart disease, asthma, or other conditions that may pose a health risk during exercise testing or respiratory gas analysis
4.Individuals with apparent lower-limb deformity or a leg length discrepancy of 1.0 cm or greater
5.Individuals with wounds, skin disorders, inflammation, or pain at the sites of contact with the knee-ankle-foot orthosis, for whom orthosis use may worsen symptoms
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Clinical Disability Sciences
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sayuuda |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Clinical Disability Sciences
Zip code
980-8574
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-728-6053
Homepage URL
sayuuda.hiroshi.q7@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
東北保健医療専門学校（宮城県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 03 | 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 | 08 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071868
