UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058283 |
|---|---|
| Receipt number | R000066630 |
| Scientific Title | The effect of Body weight-supported overground training on the walking ability of mild stroke hemiplegic patients: a single case study ABAB method. |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/26 09:24:26 |
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Basic information
Public title
The effect of Body weight-supported overground training on the walking ability of mild stroke hemiplegic patients: a single case study ABAB method.
Acronym
The effect of Body weight-supported overground training on the walking ability of mild stroke hemiplegic patients: a single case study ABAB method.
Scientific Title
The effect of Body weight-supported overground training on the walking ability of mild stroke hemiplegic patients: a single case study ABAB method.
Scientific Title:Acronym
The effect of Body weight-supported overground training on the walking ability of mild stroke hemiplegic patients: a single case study ABAB method.
Region
| Japan |
Condition
Condition
after hemorrhagic arteriovenous malformation resection
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the effect of BWSOT on walking ability in patients with mild stroke hemiplegia using the single case study ABAB method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments were performed immediately before the intervention and every 2 weeks thereafter. Primary outcomes were 10-m walking (comfortable walking speed) and 6-minute walking distance.
Key secondary outcomes
Secondary outcomes were total walking distance, Brunnstrom Recovery Stage(BRS) and Fugl-Meyer Assessment(FMA) of the lower extremities at each period.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A single-case study ABAB method design was employed, with each period of 2 weeks: period A consisted of usual physical therapy, and period B consisted of usual physical therapy plus BWSOT.
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
| 30 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
mild stroke hemiplegic patients
Key exclusion criteria
Serious stroke patients
Other than stroke patients
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Toyoshima |
Organization
Seinin-kai Rakusai Shimizu Hospital
Division name
Department of Rehabilitation
Zip code
610-1106
Address
13-107 Kutsukake-cho, Oheda, Nishikyo-ku, Kyoto-shi, Kyoto
TEL
08053352792
sho.toyosima2@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Toyoshima |
Organization
Seinin-kai Rakusai Shimizu Hospital
Division name
Department of Rehabilitation
Zip code
610-1106
Address
13-107 Kutsukake-cho, Oheda, Nishikyo-ku, Kyoto-shi, Kyoto
TEL
08053352792
Homepage URL
sho.toyosima2@gmail.com
Sponsor or person
Institute
Seinin-kai Rakusai Shimizu Hospital
Institute
Department
Personal name
Sho Toyoshima
Funding Source
Organization
no
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
Department of Rehabilitation Medicine, Rakusai Shimizu Hospital
Address
13-107 Kutsukake-cho, Oheda, Nishikyo-ku, Kyoto-shi, Kyoto
Tel
0753318778
sho-toyosima2@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
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 01 | 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
1
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066630
