UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009640 |
|---|---|
| Receipt number | R000011308 |
| Scientific Title | Assessment of the Benefits of the Addition of Botulinum Toxin A to a Repetitive Facilitative Exercise Program for the Upper Paretic Extremity in Chronic Stroke: A Randomized Controlled Study. |
| Date of disclosure of the study information | 2012/12/26 |
| Last modified on | 2021/07/04 19:33:33 |
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Basic information
Public title
Assessment of the Benefits of the Addition of Botulinum Toxin A to a Repetitive Facilitative Exercise Program for the Upper Paretic Extremity in Chronic Stroke: A Randomized Controlled Study.
Acronym
Assessment of the Benefits of the Addition of Botulinum Toxin A to a Repetitive Facilitative Exercise Program for the Upper Paretic Extremity in Chronic Stroke: A Randomized Controlled Study.
Scientific Title
Assessment of the Benefits of the Addition of Botulinum Toxin A to a Repetitive Facilitative Exercise Program for the Upper Paretic Extremity in Chronic Stroke: A Randomized Controlled Study.
Scientific Title:Acronym
Assessment of the Benefits of the Addition of Botulinum Toxin A to a Repetitive Facilitative Exercise Program for the Upper Paretic Extremity in Chronic Stroke: A Randomized Controlled Study.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the combined efficacy of a Repetitive Facilitative Exercise and the treatment with Botox (botulinum toxin A) injection for the upper paretic extremity in chronic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Myer Assessment (FMA)
Key secondary outcomes
Modified Ashworth Scale (MAS), Action Research Arm Test (ARAT), Simple Test for Evaluating Hand Function (STEF), 9 Hole Peg Test (9-HPT), Box and Block test (BBT), Functional Independence Measure (FIM), Visual Analogue Scale (VAS), Goal Attainment Scaling (GAS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The combination group of Botox injection and the Repetitive Facilitative Exercise Program
Interventions/Control_2
Control group of only the Repetitive Facilitative Exercise Program
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
| 10 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Poststroke patients hospitalized for rehabilitation
2) Obtained informed consent
3) Patients are in the post-stroke period over six month following onset.
4) History of a single stroke only
Key exclusion criteria
1) Refuse the Botox injection
2) Severe higher brain dysfunction, Severe dementia, Loss of consciousness
3) Active physical and psychological disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Shimodozono |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Rehabilitation and Physical Medicine
Zip code
8996404
Address
3930-7 Takachiho, Makizono-cho, Kirishima City, Kagoshima
TEL
0995-78-2538
rihakoza@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Hokazono |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Rehabilitation and Physical Medicine
Zip code
8996404
Address
3930-7 Takachiho, Makizono-cho, Kirishima City, Kagoshima
TEL
0995-78-2538
Homepage URL
aki88@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
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
Ethics Committee on Clinical Research, Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima
Tel
099-275-6692
kufsyomu@kuas.kagoshima-u.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
| 2012 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.jhandtherapy.org/article/S0894-1130(21)00024-7/fulltext#articleInformation
Publication of results
Published
Result
URL related to results and publications
https://www.jhandtherapy.org/article/S0894-1130(21)00024-7/fulltext#articleInformation
Number of participants that the trial has enrolled
40
Results
All participants completed this study. After 4 weeks, the intervention group evidenced a significantly greater increase in FMA score (median 11.0 [range 4-20]) than the control group (median 3.0 [range 0-9]) (P < .01, r = 0.79); as well as improvements in the other measures such as ARAT (median 12.5 [range 4-22] vs 7 [0-13]) (P < .01, r = 0.6), and MAS in the elbow flexors (median -1.5 [range -2 to 0] vs -1 [-2 to 0]) (P < .01, r = 0.45).
Results date posted
| 2021 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirteen patients had cerebral infarctions and 27 had cerebral hemorrhages. Seventeen patients had right hemiplegia and 23 had left hemiplegia, and none of the patients presented with absence of functional sensation. No significant differences were seen between the two treatment groups in demographic characteristics or baseline outcome measures.
Participant flow
Sixty-three patients with chronic stroke were screened as potential participants during the recruitment period. Fifteen patients did not satisfy the inclusion criteria and 8 declined to give consent. Forty adults with upper-limb spastic paresis after chronic stroke were enrolled and available for analysis. There were no dropouts during the 4-week study period.
Adverse events
No adverse events were observed during the trial.
Outcome measures
FMA, ARAT, active ROM, BBT, and MAS scores
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 29 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 26 | Day |
Last modified on
| 2021 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011308
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
