UMIN-CTR Clinical Trial

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
Email	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
Email	aki88@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Graduate School of Medical and Dental Sciences
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	Ethics Committee on Clinical Research, Kagoshima University Hospital
Address	8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima
Tel	099-275-6692
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011308