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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036573
Receipt No. R000041669
Scientific Title Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Date of disclosure of the study information 2019/04/22
Last modified on 2019/04/22

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Basic information
Public title Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Acronym Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Scientific Title Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Scientific Title:Acronym Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Region
Japan

Condition
Condition Stroke hemiplegia
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the rehabilitation effect of the device to prevent the foot drop of hemiplegic person
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Walking speed,stride length
2.Center of gravity
3.Floor reaction force
4.Joint angle
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 To train by using the device three times a week.
Interventions/Control_2 To perform regular physical therapy training for a week.
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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Things that can stand alone at Brunstrom Stage III (Recovery degree of motor paralysis) or higher
2.Have sufficient joint mobility (5 degrees dorsiflexion to 30 degrees dorsiflexion)
3. Those without sense of loss
4. Mini Mental State Examination (dementia diagnostic test) More than 23 points
5. Frontal Assessment Battery (frontal lobe disorder screening test) More than 12 points
Key exclusion criteria 1. Uncontrolled heart failure
2. Acute myocardial infarction
3. Active myocarditis or pericarditis
4. Unstable angina
5. Acute systemic embolism or pulmonary embolism
6. Acute infection
7. Thrombotic phlebitis
8. Ventricular tachycardia or intractable ventricular arrhythmia
9. Severe ventricular outflow tract obstruction
Ten. Uncontrolled arterial hypertension or pulmonary hypertension
11. At the same time, if you are in the target of another intervention study (verified with your physical therapist)
12. Excessive contracture
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Iwata
Middle name
Last name Hiroyasu
Organization Waseda University
Division name Faculty science and engineering
Zip code 162-0042
Address 27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
TEL 03-3203-4427
Email jubi@waseda.jp

Public contact
Name of contact person
1st name Iwata
Middle name
Last name Hiroyasu
Organization Waseda University
Division name Faculty science and engineering
Zip code 162-0042
Address 27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
TEL 03-3203-4427
Homepage URL
Email jubi@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Waseda University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Akiba Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Waseda University
Address 1-104, Totsukamachi, Shinjuku-ku, Tokyo Building 9, 2F
Tel 03-5272-1639
Email rinri@list.waseda.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 秋葉病院

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 22 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 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
2019 Year 04 Month 22 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041669

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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