UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031959
Receipt No. R000036416
Scientific Title Randomized control study of effectiveness of Welwalk WW-1000 for convalescent stroke hemiplegic patients
Date of disclosure of the study information 2018/03/29
Last modified on 2020/03/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized control study of effectiveness of Welwalk WW-1000 for convalescent stroke hemiplegic patients
Acronym Randomized control study of effectiveness of Welwalk WW-1000
Scientific Title Randomized control study of effectiveness of Welwalk WW-1000 for convalescent stroke hemiplegic patients
Scientific Title:Acronym Randomized control study of effectiveness of Welwalk WW-1000
Region
Japan

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

Objectives
Narrative objectives1 This study examined whether convalescent stroke hemiplegic patients who receive walking exercise using Welwalk WW-1000 show early improvement in independence of walking compared to patients who receive orthosis-assisted walking exercise.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Level of independence of walking
Key secondary outcomes 1) Functional Independence Measure (FIM)
2) Stroke Impairment Assessment Set(SIAS)
3) Walking performance
4) Gait pattern
5) Length of stay
6) Time after onset at the discharge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
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
Interventions/Control_1 Walking exercise using Welwalk WW-1000 for 4 weeks
Interventions/Control_2 Walking exercise using lower extremity orthosis only
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patient who satisfied the following criteria at the pre-intervension assessment within 28 days after admission and 60 days after onset
1) Patitent who or whose proxy gave written consent to participate in the study.
2) primary supratentorial intracerebral hemorrhage or cerebral infarction
3) SIAS lower extremity total score <=6
4) SIAS vertically >=2
5) FIM-walk <=3
6) FIM-comprehension >=2
7) FIM-social interaction >=3
8) FIM-memory >=3
9) Patient whose weight is >=40 kg and <95 kg
10) Patient whose height is >=140 cm and <190 cm
Key exclusion criteria Patient who satisfied the following criteria at the pre-intervension assessment within 28 days after admission and 60 days after onset
1) History of stroke
2) History of neuromuscular disease
3) Contracture of lower extremity disturbing walking
4) Excessive kyphosis
5) Participating other studies about function of lower extremity/trunk or walking
6) History of epileptic seizure within 2 years
7) Histroy of myocardial infarction or existence of symptomatic angina
8) Symptomatic arrhythmia
9) Uncontrollable hypertension; systemic blood pressure at rest >=180mmHg or diastolic blood pressure at rest <=120mmHg
10) Uncontrollable tachycardia; heart rate at rest >=120bpm
11) Symptomatic pulmonary disease
12) bone fragility of lower extremities or spine
13) Ectopic ossification of lower extremities causing limitation of range of motion of joints
14) Pregnancy or possibility of pregnancy
15) Patient who required isolation due to infections diseases
16) Incontinence of urine or faeces contaminating WW-1000
17) Patient who cannot don WW-1000 due to oversize, deformity and swelling of lower extremity
18) When the number of intervention patients exceed the upper limit of each hospital
19) Patient judged unsuitable by the principal investigator or Subinvestigator
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Eiichi
Middle name
Last name Saitoh
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Hirano
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi
TEL 0562-93-2167
Homepage URL
Email sshirano@fujita-hu.ac.jp

Sponsor
Institute Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization TOYOTA MOTOR CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Ukai Rehabilitation Hospital
Sankuro Hospital
Okayama Rehabilitation Hospital
Yufuin Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujita Health University Certified Clinical Research Review Board
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi
Tel 0562-93-2865
Email f-irb@fujita-hu.ac.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 藤田保健衛生大学病院(愛知県)
藤田保健衛生大学七栗記念病院(三重県)
医療法人珪山会鵜飼リハビリテーション病院(愛知県)
医療法人三九会三九朗病院(愛知県)
一般財団法人操風会岡山リハビリテーション病院(岡山県)
独立行政法人地域医療機能推進機構湯布院病院(大分県)
関西リハビリテーション病院(大阪府)
東京湾岸リハビリテーション病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 29 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 26 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2018 Year 03 Month 30 Day
Last follow-up date
2020 Year 03 Month 20 Day
Date of closure to data entry
2020 Year 05 Month 31 Day
Date trial data considered complete
2020 Year 05 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2020 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.