UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060767 |
|---|---|
| Receipt number | R000069372 |
| Scientific Title | Evaluation of biomechanical characteristics of hemiparetic gait during high-speed treadmill walking with ankle assist |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/02/27 12:54:15 |
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Basic information
Public title
Biomechanical evaluation of hemiparetic gait during high-speed treadmill walking with ankle assist
Acronym
AA-HSTW
Scientific Title
Evaluation of biomechanical characteristics of hemiparetic gait during high-speed treadmill walking with ankle assist
Scientific Title:Acronym
AA-HSTW-Bio
Region
| Japan |
Condition
Condition
Ambulatory stroke patients with hemiparesis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate biomechanical changes in hemiparetic gait during high-speed treadmill walking with ankle assist in individuals with post-stroke hemiparesis. Specifically, the study observationally evaluates changes in propulsive force and walking speed associated with push-off assistance. The study aims to assess gait characteristics and does not evaluate therapeutic efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in maximum 10-meter walking speed
(From baseline [before session 1] to after session 10 and 1-week follow-up)
Key secondary outcomes
1.Rate of increase in treadmill walking speed
(Ratio of Session 10 to Session 1)
2.Peak values of anterior-posterior ground reaction force
(Paretic and non-paretic limbs measured during the last 10 seconds of each session)
3.gait parameter
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will perform a high-speed treadmill walking task with an ankle assist mechanism driven by artificial muscles that provide active push-off assistance.
The initial treadmill speed will be set at 0.2 m/s below the participant's maximum walking speed and will be increased within an individually tolerable range. Each session will consist of 3 trials of 10 s, and a total of 10 sessions will be conducted.
This task is conducted to evaluate changes in gait kinematics and kinetics associated with ankle assist.
Interventions/Control_2
Participants will perform high-speed treadmill walking without ankle assist. The treadmill speed and task volume will be identical to those of the assist condition. This condition is included solely for biomechanical comparison and does not represent a therapeutic control.
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
| 47 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Hemiparetic stroke patients within 6 months post-onset.
2.Ability to walk independently using an ankle-foot orthosis and a cane.
3.Provision of written informed consent for study participation
Key exclusion criteria
1.Presence of bone or joint diseases affecting gait.
2.Gait disturbance caused by neuromuscular diseases other than the primary stroke.
3.Inability to follow test instructions due to aphasia or dementia.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Shinmei |
Organization
Gakkentoshi Hospital
Division name
Department of Rehabilitation
Zip code
619-0238
Address
7-4-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0238, Japan
TEL
+81-774-98-2123
toshihide0206401@gmail.com
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Shinmei |
Organization
Gakkentoshi Hospital
Division name
Department of Rehabilitation
Zip code
619-0238
Address
7-4-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0238, Japan
TEL
+81-774-98-2123
Homepage URL
toshihide0206401@gmail.com
Sponsor or person
Institute
Gakkentoshi Hospital
Institute
Department
Personal name
Toshihide shinmei
Funding Source
Organization
None
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
Institutional Review Board, Gakkentoshi Hospital
Address
7-4-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0238, Japan
Tel
+81-774-98-2123
fukata@iseikai.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
学研都市病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069372
