UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054317 |
|---|---|
| Receipt number | R000062049 |
| Scientific Title | An Examination of Factors Influencing Physical Therapists' Judgment of Walking "Independent" in Stroke Patients |
| Date of disclosure of the study information | 2024/05/04 |
| Last modified on | 2024/05/04 18:02:07 |
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Basic information
Public title
What Influences Physical Therapists' Judgment of Walking "Independent" in Stroke Patients?
Acronym
What influences a stroke patient's decision to walk "independent"?
Scientific Title
An Examination of Factors Influencing Physical Therapists' Judgment of Walking "Independent" in Stroke Patients
Scientific Title:Acronym
What influences a stroke patient's decision to walk "independently"?
Region
| Japan |
Condition
Condition
Subacute stroke hemiplegic individuals.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine differences in gait between independent vs. non-independent groups in patients with stroke hemiplegia who exceed the criteria for walking Independent.
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Ambulation Categories
Spatiotemporal gait parameters
Key secondary outcomes
Age, Use of cane and orthotics, FMA-UE, FMA-LE, FMA-balance, FMA-sensation, FMA-Passive joint motion, FMA-Joint pain, Trunk control test, modified ashworth scale of the ankle joint, Knee joint extension muscle strength, Mini Mental State Examination
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Less than 180 days from onset
2)Patient has motor disability in one lower limb.
3) Able to walk with observation or touch, which is the criteria for in-hospital walking independence.
4) Walking speed of more than 0.59 m/s
5)Total bilateral knee joint extensor muscle strength is 1.31Nm/kg or more.
Key exclusion criteria
1)Subjects with impaired consciousness.
2)Subjects with cognitive decline, aphasic symptoms, higher brain dysfunction that are difficult to understand in this study.
3)Subjects with cardiovascular or respiratory disease that limit training.
4)Subjects with lower limb osteoarthritis that limit training.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kouta |
| Middle name | |
| Last name | kunitomo |
Organization
Ushioda General Hospital
Division name
Department of Rehabilitation
Zip code
230-0001
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL
045-574-1316
24s3070@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | kouta |
| Middle name | |
| Last name | kunitomo |
Organization
Ushioda General Hospital
Division name
Department of Rehabilitation
Zip code
230-0001
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL
045-574-1316
Homepage URL
24s3070@g.iuhw.ac.jp
Sponsor or person
Institute
Ushioda General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ushioda General Hospital
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
Tel
045-574-1316
rihabiri@ushioda.or.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
| 2024 | Year | 05 | Month | 04 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measuring the gait of stroke paraplegics using a gait measurement sheet.
Management information
Registered date
| 2024 | Year | 05 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062049
