UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054825 |
|---|---|
| Receipt number | R000062641 |
| Scientific Title | Effectiveness of Body weight supported overground training(BWSOT) for Hemiplegic Stroke Patients |
| Date of disclosure of the study information | 2024/06/29 |
| Last modified on | 2024/06/29 19:10:25 |
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Basic information
Public title
Effectiveness of Body weight supported overground training(BWSOT) for Hemiplegic Stroke Patients
Acronym
Effectiveness of Body weight supported overground training(BWSOT) for Hemiplegic Stroke Patients
Scientific Title
Effectiveness of Body weight supported overground training(BWSOT) for Hemiplegic Stroke Patients
Scientific Title:Acronym
Effectiveness of Body weight supported overground training(BWSOT) for Hemiplegic Stroke Patients
Region
| Japan |
Condition
Condition
New stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Gait reconstruction for stroke paraplegic patients involves gait practice using a suspended weight unloading device. Suspension devices are used on treadmills or on level ground and are called Body Weight Supported Treadmill Training (BWSTT) and Body Weight Supported Overground Training (BWSOT).
BWSOT uses suspended weight bearing to provide direct level walking practice in a safe condition. In other words, it allows for a repetitive, task oriented approach with difficulty adjustment while retaining the specificity of level walking. The amount of training and the specificity and difficulty of the task are considered important for improving the walking ability of stroke paraplegic patients, and BWSOT can provide walking practice that includes both factors. However, previous studies have not clarified the therapeutic effects of BWSOT on walking ability improvement, including indications based on the severity of paralysis, and the evidence for this has not been established. Therefore, demonstrating the therapeutic efficacy of BWSOT for stroke hemiplegia patients may allow us to propose safe and effective practice methods.
This study will analyze trends in BWSOT treatment efficacy on a case by case basis using a single case study design as a preliminary step in a larger intervention study. The purpose of this study is to identify trends in the treatment effects of BWSOT for stroke hemiplegia patients and to provide basic data for determining the indications of BWSOT according to the severity of paralysis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each evaluation will be conducted initially and every 2 weeks for a total of 2 months.
10m walking speed (maximum walking speed and comfortable walking speed) *Including number of steps and walking rate
Timed Up & Go test (TUG)
Key secondary outcomes
Berg Balance Scale (BBS)
Brunnstrom Recovery Stage (BRS)
Fugl Meyer assessment (FMA)
6-minute walk
Functional Independence Measure
Stroke Specific QOL Scale (SS QOL)
Walking style (unaided, T cane, four point cane, parallel bars assisted walking, unassisted walking)
Functional Ambulation Categories (FAC)
based on the amount of assistance
Total daily practice walking (m)
Total practice walking in each period (m)
Base
Study type
Interventional
Study design
Basic design
n-of-1
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
The A-B-A-B method of single case study will be used, with Period A being standard physical therapy and Period B being standard physical therapy plus BWSOT intervention. Each period will be 2 weeks, for a total of 8 weeks of intervention study. The standard physical therapy will consist of approaches related to functional recovery, balance exercises, transfer and standing exercises, activities of daily living exercises, and gait exercises. The gait practice will be the usual gait practice in Period A and BWSOT intervention in Period B.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients must be new stroke patients admitted to the recovery unit. The inclusion criteria will be 5 new stroke patients with Brunnstrome stage (Brs) I or higher or Functional Independence Measure (FIM) 1 or higher.
Eligible patients will be those with severe (Brs1-2), moderate (Brs 3-4), and mild (Brs 5-6) stroke.
Key exclusion criteria
Exclusion criteria: patients with subarachnoid hemorrhage and submental lesions.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Morishita |
Organization
Josai International University
Division name
Graduate School of Health Sciences
Zip code
283-0002
Address
1 Gumyo, Tougane City, Chiba Prefecture
TEL
0475-55-8811
morishita@jiu.ac.jp
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
0753318778
Homepage URL
sho.toyosima2@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Rakusai Shimizu Hospital
Sho Toyoshima
Institute
Department
Personal name
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
075-331-8778
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 29 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2024 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062641
