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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023092
Receipt No. 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

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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
Email 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
Email yutti@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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