UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018683 |
|---|---|
| Receipt number | 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 00:25:19 |
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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
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
a.tanuma.sy@juntendo.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
