UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031959 |
|---|---|
| Receipt number | 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 10:59:00 |
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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
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
sshirano@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036416
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| Registered date | File name |
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