UMIN-CTR Clinical Trial

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
Last 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
1st 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