UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062115 |
|---|---|
| Receipt number | R000071079 |
| Scientific Title | Effects of postural-control motor tasks on paretic-side weight-bearing ratio and center-of-pressure sway in patients with acute stroke hemiplegia |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 09:24:54 |
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Basic information
Public title
Effects of weight-bearing training using a Perceptual Stimulus Insole (PSI) on standing balance in patients with post-stroke hemiplegia
Acronym
PSI standing balance trial
Scientific Title
Effects of postural-control motor tasks on paretic-side weight-bearing ratio and center-of-pressure sway in patients with acute stroke hemiplegia
Scientific Title:Acronym
PSI weight-bearing RCT in acute hemiplegia
Region
| Japan |
Condition
Condition
Acute post-stroke hemiplegia
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine, in patients with acute post-stroke hemiplegia, the effects and characteristics of postural-control motor tasks including weight-bearing training with a Perceptual Stimulus Insole (PSI) on paretic-side weight-bearing ratio and center-of-pressure sway.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Paretic-side lower-limb weight-bearing ratio during standing tests (measured before and immediately after the intervention)
Key secondary outcomes
[Measured before and immediately after the intervention] Center-of-pressure (COP) indices in eyes-open static standing; center-of-pressure excursion in the eyes-open limits-of-stability test (four directions); Functional Reach Test (FRT); and a semi-structured interview on standing.
[Measured at baseline only] Fugl-Meyer Assessment lower-extremity motor (FMA-LE) and sensory (FMA-S) subscales; knee extension strength (hand-held dynamometer); Functional Assessment for Control of Trunk (FACT); Berg Balance Scale (BBS); Mini-Mental State Examination (MMSE); Trail Making Test part A (TMT-A); and Frontal Assessment Battery (FAB).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
In addition to standard physical therapy, participants wear a Perceptual Stimulus Insole (PSI) and perform weight-bearing training toward the paretic and non-paretic sides, with weight position taught through plantar sensory input. The weight-bearing training consists of 4 sets over 10 minutes. All assessments are performed without the PSI, before and immediately after the intervention.
Interventions/Control_2
In addition to standard physical therapy, participants perform weight-bearing training toward the paretic and non-paretic sides with verbal instruction of weight position. The weight-bearing training consists of 4 sets over 10 minutes (identical intervention time and standard physical therapy as the intervention group).
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with acute post-stroke hemiplegia presenting unilateral motor paresis due to cerebrovascular disease; able to understand task instructions; able to stand up and maintain standing independently; and willing to participate in the study.
Key exclusion criteria
Patients with impaired consciousness; severe aphasia, apraxia, or agnosia; or orthopedic disorders affecting postural control.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Prefectural University of Hiroshima
Division name
Physical Therapy Course, Faculty of Health and Welfare
Zip code
7230053
Address
1-1 Gakuen-cho, Mihara, Hiroshima
TEL
0848601230
m-hasegawa@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Prefectural University of Hiroshima
Division name
Physical Therapy Course, Faculty of Health and Welfare
Zip code
7230053
Address
1-1 Gakuen-cho, Mihara, Hiroshima
TEL
0848601230
Homepage URL
m-hasegawa@pu-hiroshima.ac.jp
Sponsor or person
Institute
NHO Shikoku Medical Center for Children and Adults
Institute
Department
Personal name
Yohei Kondo
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Institutional Review Board, NHO Shikoku Medical Center for Children and Adults
Address
2603 Zentsuji-cho, Zentsuji, Kagawa, Japan
Tel
0877621000
r624008fi@ed.pu-hiroshima.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
独立行政法人 国立病院機構 四国こどもとおとなの医療センター（香川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 02 | 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 | 01 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 08 | 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 | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071079
