UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034270 |
|---|---|
| Receipt number | 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 | 2022/09/29 09:47:52 |
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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, immediately after(at first intervention), 2 weeks after, and 3months 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
| Device,equipment |
Interventions/Control_1
ergometer exercis/experimental group
period:15min(10 min only for the first time)
pedal load:5 N-m
pedal rotation:40 rpm
frequency:2times a day, 20 times in 2 weeks
Interventions/Control_2
walking/control group
period:15 min
speed:comfortable
frequency:2times a day, 20 times in 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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. unilateral cerebral lesions, 2. at least 6 months since the onset of stroke, 3. ability to walk independently or under supervision and use or nonuse of a cane but no brace, 4. ability to pedal or walk for 10 min continuously, and 5. stiff-knee gait determine under the following conditions: peak knee flexion during the swing phase, knee range of motion during the early swing phase, total knee range of motion, and timing of peak knee flexion during the swing phase. A limb is classified as stiff if 3 or more of these measures are 2 standard deviations below the average control value. Control data are collected from able-bodied subjects of approximately the same average age, height, and weight as the subjects.
Key exclusion criteria
1. decreased knee joint range of motion at rest, 2. history of lower-limb joint surgery, 3. Mini-Mental State Examination score less than 24 points, and 4. treatment received for cardiovascular disease.
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
k.fujita@fukui-hsu.ac.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
k.fujita@fukui-hsu.ac.jp
Sponsor or person
Institute
Fukui Health Science University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1052305720304535
Number of participants that the trial has enrolled
45
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
Main results already published
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
| 2023 | 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
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039070
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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