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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034270
Receipt No. R000039070
Scientific Title Can the ergometer exercise improve stiff knee gait for the patient with stroke?
Date of disclosure of the study information 2018/10/01
Last modified on 2019/09/27

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Basic information
Public title Can the ergometer exercise improve stiff knee gait for the patient with stroke?
Acronym Can the ergometer exercise improve stiff knee gait?
Scientific Title Can the ergometer exercise improve stiff knee gait for the patient with stroke?
Scientific Title:Acronym Can the ergometer exercise improve stiff knee gait?
Region
Japan

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

Objectives
Narrative objectives1 Can the ergometer exercise improve stiff knee gait for the patient with stroke?
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Motion analysis and electromyogram during walking are measured before intervention, 2 weeks after intervention and 3 months after intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 ergometer exercise: 2 weeks/walking exercise: 2 weeks
Interventions/Control_2 physical therapy; 2 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
30 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Unilateral lesions in the cerebrum; 2. At least 6 months since stroke onset; 3. Walking ability at monitoring level or higher; 4. Walking speed of 0.1 to 1 m/s; 5. The knee joint angle of the swing phase during walking is decreasing; 6. Spasticity of at least 1+ on the modified Ashworth scale in the knee extensor muscle.
Key exclusion criteria 1. The Ergometer and gait difficult to exercise alone; 2. Higher brain dysfunction that presents problems for intervention and/or evaluation; 3. Cardiovascular disease that restricts exercise.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuki
Middle name
Last name Fujita
Organization Fukui Health Science University
Division name Faculty of Health Science, Department of Rehabilitation Physical Therapy
Zip code 910-3190
Address Egami 55-13-1, Fukuishi, Fukui, 910-3190, Japan
TEL 0776-59-2200
Email k.fujita-fchs@kvj.biglobe.ne.jp

Public contact
Name of contact person
1st name Kazuki
Middle name
Last name Fujita
Organization Fukui Health Science University
Division name Faculty of Health Science, Department of Rehabilitation Physical Therapy
Zip code 910-3190
Address Egami 55-13-1, Fukuishi, Fukui, 910-3190, Japan
TEL 0776-59-2200
Homepage URL
Email k.fujita-fchs@kvj.biglobe.ne.jp

Sponsor
Institute Fukui Health Science University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Promotion and Mutual Aid Corporation for Private School of Japan

IRB Contact (For public release)
Organization Nittazuka Medical Welfare Center
Address 58-16-1, Egami, Fukui-city, Fukui
Tel 0776-59-1300
Email fgh-hisyo@mopera.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 福井総合病院(福井県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 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
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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 30 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 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
2018 Year 09 Month 26 Day
Last modified on
2019 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039070

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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