UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023092 |
|---|---|
| Receipt number | R000026614 |
| Scientific Title | Effects of Intensive Rehabilitation after Botulinum Toxin Type A Injection on Gait in Chronic Post-Stroke Patients |
| Date of disclosure of the study information | 2016/07/10 |
| Last modified on | 2016/07/10 02:30:00 |
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Basic information
Public title
Effects of Intensive Rehabilitation after Botulinum Toxin Type A Injection on Gait in Chronic Post-Stroke Patients
Acronym
Effects of Rehabilitation after Botulinum Toxin Type A Injection
Scientific Title
Effects of Intensive Rehabilitation after Botulinum Toxin Type A Injection on Gait in Chronic Post-Stroke Patients
Scientific Title:Acronym
Effects of Rehabilitation after Botulinum Toxin Type A Injection
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to examine the effects of intensive rehabilitation following botulinum toxin type A injection on gait for patients with lower-limb spasticity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The modified Ashworth scale of ankle plantar flexor, range of motion of ankle dorsiflexion, 10-meter walking test, 6-minute walking distance test, timed up and go test, and Berg balance scale at every 2-week follow-up after BoNT-A injection.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
post-stroke hemiparesis, lower-limb spasticity causing gait disturbance, 6 months or more after stroke onset, spastic drop foot by a score of 2 or more for ankle flexors on the modified Ashworth scale, no history of BoNT-A injection for lower-limb spasticity, gait assessed by functional independence measure score 5 or more.
Key exclusion criteria
No remarkable higher brain dysfunction affecting gait disturbance.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Domen |
Organization
Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6881
domen@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Uchiyama |
Organization
Sasayama Medical Center, Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
Kuro-oka 5, Sasayama, Hyogo
TEL
079-552-1181
Homepage URL
yutti@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
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
Address
Tel
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
兵庫医科大学ささやま医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyses showed statistically significant improvements in 10-meter walking test(10MWT) and 6-minute walking distance test(6MD) for both groups. In group II, the 10MWT and 6MD improved much more during the last 4 weeks after BoNT-A injection than during the first 4 weeks before BoNT-A injection.
Management information
Registered date
| 2016 | Year | 07 | Month | 10 | Day |
Last modified on
| 2016 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026614
| 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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| Registered date | File name |
