UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042313
Receipt number R000048306
Scientific Title Functional prognosis prediction for the effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis
Date of disclosure of the study information 2020/11/01
Last modified on 2020/11/01 16:02:36

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Basic information

Public title

Functional prognosis prediction for the effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis

Acronym

The effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis

Scientific Title

Functional prognosis prediction for the effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis

Scientific Title:Acronym

The effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis

Region

Japan


Condition

Condition

Post stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

By analyzing BoNT-A and intensive rehabilitation for patients with post-stroke upper limb hemiparesis by a more detailed classification of upper limb function, the effect is verifyand the functional prognosis is predicted.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The Fugl-Meyer Assessment (FMA)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

botulinum toxin A + intensive rehabilitation

Interventions/Control_2

usual rehabilitation

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) patients with hemiplegia following a stroke that involved upper limb spasticity (with a Modified Ashworth Scale score equal to or greater than 1; (2) >6 months since the onset of stroke; (3) no prior BoNT- A injections; (4) no contraindications for BoNT-A injections.

Key exclusion criteria

(1) taking anti-spasticity medications, and (2) a history of BoNT-A injections.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Takatoshi
Middle name
Last name Hara

Organization

The Jikei University School of Medicine

Division name

Department of Rehabilitaion Medicine

Zip code

105-8461

Address

Department of Rehabilitaion Medicine

TEL

+81-3-3433-1111

Email

t_hara1019@jikei.ac.jp


Public contact

Name of contact person

1st name Takatoshi
Middle name
Last name Hara

Organization

The Jikei University School of Medicine

Division name

Department of Rehabilitaion Medicine

Zip code

105-8461

Address

3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo 105-8461, Japan

TEL

+81-3-3433-1111

Homepage URL


Email

t_hara1019@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None declared.

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

The Jikei University School of Medicine

Address

3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo 105-8461, Japan

Tel

+81-3-3433-1111

Email

t_hara1019@jikei.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

2020 Year 11 Month 01 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

130

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

Completed

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB

2014 Year 03 Month 01 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2020 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

2020 Year 11 Month 01 Day

Last modified on

2020 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name