UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048477 |
|---|---|
| Receipt number | R000055240 |
| Scientific Title | Effect of gait training using Welwalk and Botulinum Toxin A Injection on gait ability in chronic stroke patients |
| Date of disclosure of the study information | 2022/07/27 |
| Last modified on | 2023/07/28 17:54:40 |
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Basic information
Public title
Effect of gait training using Welwalk and Botulinum Toxin A Injection on gait ability in chronic stroke patients
Acronym
Combined effects of gait training using Welwalk and Botulinum Toxin A Injection in chronic stroke patients
Scientific Title
Effect of gait training using Welwalk and Botulinum Toxin A Injection on gait ability in chronic stroke patients
Scientific Title:Acronym
Combined effects of gait training using Welwalk and Botulinum Toxin A Injection in chronic stroke patients
Region
| Japan |
Condition
Condition
Chronic stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of gait training using Welwalk and Botulinum Toxin A Injection on gait ability in chronic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait analysis
Key secondary outcomes
Range of motion (knee, ankle)
Modified Ashworth Scale (MAS)
10m gait velocity
6-minute walk distance
Timed up to Go
Global rating of change scale
MOS Physical Cost Index8-Item Short-Form Health Survey
Physical Cost Index
Physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Gait exercise using Welwalk after botulinum toxin type A therapy (40 min/day, 5 days/week for 4 weeks)
Interventions/Control_2
Botulinum Toxin A Injection alone
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.>6 months duration after stroke
2.Hemiparesis and spasticity due to ischemic or hemorrhage on the unilateral tent (lower extremity modified Ashworth Scale of more than 1+)
3.Independent in ground ambulation with or without the use of a unilateral assistive device (standard cane, four-pronged cane) and with or without the use of a an ankle foot orthoses.
4.Independent in treadmil gait training
5.Approval for study participation
Key exclusion criteria
1.Cannot obey instructions of a healer (scores < 23 on the Mini Mental Status examination, etc)
2.Significant cardiorespiratory/metabolic disease, or orthopedic injury or other neurological
3.Excessive spasticity (defined as modified Ashworth scale 4 at any lower limb joint)
4.Size limitations for the harness/counterweight system or robotic orthosis
5.Receiving anti-spasticity therapy (Botulinum Toxin A, phenol, baclofen pump, etc.) in the lower extremities within 16 weeks of study entry
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Ogino |
Organization
Hyogo medical university
Division name
School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo, 650-8530, Japan
TEL
078-304-3184
to-ogino@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Ogino |
Organization
Hyogo medical university
Division name
School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo, 650-8530, Japan
TEL
078-304-3184
Homepage URL
to-ogino@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo medical university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hyogo medical university
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
Tel
0798-45-6111
rinsys@hyo-med.ac.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
| 2022 | Year | 07 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055240
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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