UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059538 |
|---|---|
| Receipt number | R000068102 |
| Scientific Title | The Cutoff Value for Gait Independence Based on Stride Time Variability in Stroke Patients |
| Date of disclosure of the study information | 2025/10/26 |
| Last modified on | 2025/10/25 15:19:51 |
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Basic information
Public title
The Cutoff Value for Gait Independence Based on Stride Time Variability in Stroke Patients
Acronym
The Relationship Between Gait Stability and Independence in Stroke Rehabilitation
Scientific Title
The Cutoff Value for Gait Independence Based on Stride Time Variability in Stroke Patients
Scientific Title:Acronym
The Relationship Between Gait Stability and Independence in Stroke Rehabilitation
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the influence of STV on gait independence patients with stroke and identify a clinically applicable cutoff value.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stride time variability
Locomotion item score of the Functional Independence Measure
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were able to walk with at least minimal assistance during rehabilitation
Patients who were able to walk independently or using a T-cane
Key exclusion criteria
patients who had difficulty performing tasks due to higher brain dysfunction
had difficulty understanding instructions
had pre-existing conditions affecting gait function
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | Yusuke Harada |
| Last name | Harada |
Organization
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Division name
Department of Rehabilitation Medicine
Zip code
260-0026
Address
4-4 Chibaminato, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-242-0180
t.sawataishi.0528@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | Yusuke Harada |
| Last name | Harada |
Organization
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Division name
Department of Rehabilitation Medicine
Zip code
260-0026
Address
4-4 Chibaminato, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-242-0180
Homepage URL
harada1111.0917@gmail.com
Sponsor or person
Institute
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
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
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Address
4-4 Chibaminato, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-242-0180
harada1111.0917@gmail.com
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 | 10 | Month | 26 | 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
92
Results
Of the 92 participants, 48 were classified into the independent walking group. The independent walking group had significantly lower STV compared with the non-independent walking group (n = 44). STV was a significant predictor of gait independence (odds ratio = 0.79, p = 0.044), with an AUC of 0.742. The cutoff value was 3.5%, with a sensitivity of 68% and specificity of 73%.
Results date posted
| 2025 | Year | 10 | Month | 25 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: This study employed a cross-sectional observational design.
All assessments, except for the FIM, were conducted within one week prior to the participants' scheduled discharge date. The FIM was assessed on the day of discharge.
Management information
Registered date
| 2025 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068102
