UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059482 |
|---|---|
| Receipt number | R000067956 |
| Scientific Title | Mechanical Interventions and Their Effects on Gait Rehabilitation After Stroke |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/10/21 10:37:59 |
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Basic information
Public title
A Study to Evaluate the Effectiveness of Machine-Assisted Gait Training in Patients with Stroke
Acronym
MAST
Scientific Title
Mechanical Interventions and Their Effects on Gait Rehabilitation After Stroke
Scientific Title:Acronym
MEGARS
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, functional electrical stimulation (FES) is applied to the gastrocnemius and soleus muscles of hemiparetic patients during body weight-supported walking. The aim is to identify the optimal combination of electrical stimulation and body weight support level. This study is expected to broaden the rehabilitation options for hemiparetic patients who exhibit diverse gait patterns.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle joint torque(during functional electrical stimulation)
Vertical ground reaction force(during functional electrical stimulation)
Anterior-posterior ground reaction force(during functional electrical stimulation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
FES to the soleus muscle,0% BWS (no unloading)
Interventions/Control_2
FES to the soleus muscle,15% BWS
Interventions/Control_3
FES to the soleus muscle,30% BWS
Interventions/Control_4
FES to the gastrocnemius muscle,0% BWS (no unloading)
Interventions/Control_5
FES to the gastrocnemius muscle,15% BWS
Interventions/Control_6
FES to the gastrocnemius muscle,30% BWS
Interventions/Control_7
FES to the triceps surae (soleus + gastrocnemius),0% BWS (no unloading)
Interventions/Control_8
FES to the triceps surae (soleus + gastrocnemius),15% BWS
Interventions/Control_9
FES to the triceps surae (soleus + gastrocnemius),30% BWS
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic stroke patients with hemiparesis who are able to walk independently, excluding those who require walking aids.
Key exclusion criteria
1.CognitiveCognitive impairment, as assessed by the Mini-Mental State Examination (MMSE).
 Participants scoring 27 or lower on the MMSE will be excluded.
2.Cardiac diseases, including heart failure, angina pectoris, or other life-threatening arrhythmias.
3.Respiratory diseases, such as chronic obstructive pulmonary disease (COPD) or lung cancer.
4.Allergies to medications or metals.
5.Markedly reduced exercise tolerance.
6.Contraindications to functional electrical stimulation (FES) used in this study, including:
Abnormal pain, numbness, or sensory disturbances in the affected lower limb, Presence of a pacemaker, Metal implants in the lower limbs, Skin disorders, History or suspicion of epilepsy
7.Participants whose gait does not show a clear difference from that of healthy individuals, or who do not exhibit obvious impairment in push-off during gait, which is the focus of this study.
8.Individuals who require walking aids.
9.Those who require more than one hour of round-trip transportation to and from the research site.
10.Individuals who have difficulty gripping handrails or operating switches.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hirai |
Organization
The University of Osaka
Division name
Graduate School of Engineering Science
Zip code
560-8531
Address
1-3 Machikaneyama-cho, Toyonaka, Osaka, Japan
TEL
06-6850-6206
hirai@me.es.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Kuga |
Organization
The University of Osaka
Division name
Graduate School of Engineering Science
Zip code
560-8531
Address
1-3 Machikaneyama-cho, Toyonaka, Osaka, Japan
TEL
06-6850-6206
Homepage URL
kuga@hmc.me.es.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Research Ethics Committee
Address
1-1 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel
06-6879-4202
kensui-kensui-life@office.osaka-u.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
| 2025 | Year | 12 | 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
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
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067956
