UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054671 |
|---|---|
| Receipt number | R000060798 |
| Scientific Title | Immediate effect of body weight supported walker with or without unloading on gait of stroke hemiplegic patients. |
| Date of disclosure of the study information | 2024/06/16 |
| Last modified on | 2025/12/17 21:55:19 |
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Basic information
Public title
Immediate effect of body weight supported walker with or without unloading on gait of stroke hemiplegic patients.
Acronym
Immediate effect of body weight supported walker with or without unloading on gait of stroke hemiplegic patients.
Scientific Title
Immediate effect of body weight supported walker with or without unloading on gait of stroke hemiplegic patients.
Scientific Title:Acronym
Immediate effect of body weight supported walker with or without unloading on gait of stroke hemiplegic patients.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the immediate effects of unloaded and unloaded gait practice on the use of a body weight supported walker for stroke hemiplegic patients, after identifying the differences in gait parameters between walker walking and unloaded plus walker walking.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
speed,stride length,cadence,symmetry ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To verify the difference in gait parameters between unweighted and unweighted, and to test the immediate effect of unweighted and unweighted gait practice, the subjects will be randomly assigned to two groups, Group A and Group B. Group A will receive 10 minutes of unweighted gait practice for the first time, and Group B will receive 10 minutes of unweighted gait practice (25% of body weight) for the first time. A 7-day washout period will be allowed, and the conditions of each group will be switched on the following day. Gait parameters with and without unloading during gait practice will also be evaluated.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have suffered a stroke and have hemiplegia.
Able to walk more than 16 meters.
Key exclusion criteria
Persons who have difficulty in walking.
Persons who are judged to be inappropriate to participate in the study by a physician or physiotherapist.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | hiroo |
| Middle name | |
| Last name | koshisaki |
Organization
Nanto Municipal Hospital
Division name
Department of Rehabilitation
Zip code
932-0211
Address
938 Inami, Nanto, Toyama
TEL
0763-82-1475
hiroo.koshisa@gmail.com
Public contact
Name of contact person
| 1st name | koshisaki |
| Middle name | |
| Last name | hiroo |
Organization
Nanto Municipal Hospital
Division name
Department of Rehabilitation
Zip code
932-0211
Address
938 Inami, Nanto, Toyama
TEL
0763-82-1475
Homepage URL
hiroo.koshisa@gmail.com
Sponsor or person
Institute
Nanto Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Nanto Municipal Hospital
Address
938 Inami, Nanto, Toyama
Tel
0763-82-1475
hiroo.koshisa@gamil.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
| 2024 | Year | 06 | Month | 16 | 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
20
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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060798
