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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018683
Receipt No. R000021615
Scientific Title Pedaling exercise for stroke patients with spastic hemiparesis: Randomized control study
Date of disclosure of the study information 2015/08/14
Last modified on 2021/03/01

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Basic information
Public title Pedaling exercise for stroke patients with spastic hemiparesis: Randomized control study
Acronym Pedaling exercise for stroke
Scientific Title Pedaling exercise for stroke patients with spastic hemiparesis: Randomized control study
Scientific Title:Acronym Pedaling exercise for stroke
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the efficacy of pedaling exercise for stroke patients with spastic hemiparesis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes muscle strength of lower extremities at the time of the end of intervention
Key secondary outcomes hemiparesis, balance, gait analysis, electrophysiological study at the time of the end of intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 pedaling exercise for 4 weeks
Interventions/Control_2 active knee extension and flexion exercise for 4 weeks
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Time from stroke onset >1 month
Spasticity of affected ankle plantarflexor, MAS >1
Moderate or severe paresis of lower extremity, SIAS knee extension test <4 and SIAS foot pad test <4
Capacity to give informed consent of this study
Key exclusion criteria Severe heart diseases and hypertension
Neuromuscular diseases
Other serious medical condition
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Tanuma
Organization Juntendo Shizuoka Hospital
Division name Department of Rehabilitation Medicine
Zip code 410-2295
Address 1129 Nagaoka, Izunokuni, Shizuoka, 410-2295 Japan
TEL 055-948-3111
Email a.tanuma.sy@juntendo.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Tanuma
Organization Juntendo Shizuoka Hospital
Division name Department of Rehabilitation Medicine
Zip code 410-2295
Address 1129 Nagaoka, Izunokuni, Shizuoka, 410-2295 Japan
TEL 055-948-3111
Homepage URL
Email a.tanuma.sy@juntendo.ac.jp

Sponsor
Institute Department of Rehabilitation Medicine, Keio University
Institute
Department

Funding Source
Organization Self funding
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 Tokyo Bay Rehabilitation Hospital
Address 4-1-1 Yatsu, Narashino, Chiba, 275-0026 Japan
Tel 047-453-9000
Email shinsakai@wanreha.net

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
2015 Year 08 Month 14 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 24
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
2008 Year 06 Month 30 Day
Date of IRB
2008 Year 07 Month 22 Day
Anticipated trial start date
2009 Year 04 Month 24 Day
Last follow-up date
2022 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
2015 Year 08 Month 14 Day
Last modified on
2021 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021615

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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