UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062177 |
|---|---|
| Receipt number | R000071150 |
| Scientific Title | Effects of Foot Care on Gait Performance in Individuals with Subacute Stroke: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/08 18:59:59 |
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Basic information
Public title
Effects of Foot Care on Walking Performance in Individuals with Hemiplegia After Stroke
Acronym
FCG Study
Scientific Title
Effects of Foot Care on Gait Performance in Individuals with Subacute Stroke: A Randomized Crossover Trial
Scientific Title:Acronym
FCG Study
Region
| Japan |
Condition
Condition
Subacute stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of foot care consisting of foot bathing and foot massage on gait performance in individuals with subacute stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Walking speed measured at baseline, immediately after the first intervention, after 3 weeks, and after 6 weeks
Key secondary outcomes
Step length, cadence, maximum heel pressure, Symmetry Index, foot contact position, hip joint angle, knee joint angle, ankle joint angle, paretic elbow flexion angle, and lateral center of mass displacement measured at baseline, immediately after the first intervention, after 3 weeks, and after 6 weeks.
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Group A: Foot care consisting of a 10-minute foot bath at 40 degrees C followed by a 20-minute foot massage, three times per week for 3 weeks, followed by a 3-week non-intervention period.
Interventions/Control_2
Group B: A 3-week non-intervention period followed by foot care consisting of a 10-minute foot bath at 40 degrees C and a 20-minute foot massage, three times per week for 3 weeks.
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
| 30 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. First-ever stroke
2. Hemiplegia
3. Within 180 days after stroke onset
4. Age>30 years
5. Able to walk under supervision
6. Written informed consent obtained
Key exclusion criteria
1. Deep vein thrombosis
2. Severe heart failure
3. Severe skin disease
4. Orthopedic disorders affecting gait
5. Inability to understand study procedures
6. Judged unsuitable by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Osada |
Organization
Tokushima Bunri University
Division name
Faculty of Health and Welfare Department of Physical Therapy
Zip code
7708514
Address
Nishihamahoji-180, Yamashirocho, Tokushima
TEL
+81-88-602-8719
osada@tks.bunri-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Osada |
Organization
Tokushima Bunri University
Division name
Faculty of Health and Welfare Department of Physical Therapy
Zip code
7708514
Address
Nishihamahoji-180, Yamashirocho, Tokushima
TEL
+81-88-602-8719
Homepage URL
osada@tks.bunri-u.ac.jp
Sponsor or person
Institute
Tokushima Bunri University
Institute
Department
Personal name
Yuji Osada
Funding Source
Organization
Tokushima Bunri University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Taoka Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima Bunri University Ethics Review Committee
Address
Nishihamahoji-180, Yamashirocho, Tokushima
Tel
+81-88-602-8000
osada@tks.bunri-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
Tokushima
Institutions
Institutions
田岡病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 08 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2028 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071150
