UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042627 |
|---|---|
| Receipt number | R000048643 |
| Scientific Title | Effects of gait exercise walking assist robot on the hemiplegic stroke |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2024/01/12 13:21:32 |
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Basic information
Public title
Effects of gait exercise walking assist robot on the hemiplegic stroke
Acronym
Effects of gait exercise walking assist robot
Scientific Title
Effects of gait exercise walking assist robot on the hemiplegic stroke
Scientific Title:Acronym
Effects of gait exercise walking assist robot
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the knee joint flexion / extension assist by walking assist robot for gait exercise on the hemiplegic stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking video
Key secondary outcomes
10m gait velocity
Modified Ashworth Scale(MAS)
Global Rating of Change scale(GRC)
Cadence
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects receives gait training using gait exercise assist robot for 10 min
Interventions/Control_2
Subjects receives gait training on treadmill for 10 min
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Height not less than 140cm and less than 190cm
2. Weight is 35kg or more and less than 95kg
3. Approval for study participation
4. First stroke(supratentorial)
Gait ability is 3 or more in Functional Ambulation Category(FAC)
Key exclusion criteria
1.Bilateral hemiplegia
2.Ataxia
3.Possibility of contaminating robots
4.Cannot obey instructions of a healer due to dementia or severe higher brain dysfunction
5.High blood pressure with poor control(Systolic blood pressure of 160mmHg or more or diastolic blood pressure of 100mmHg or more
6.At resting heart beat 100 times / min or more
7.Severe joint contracture and deformity
8.Sight impairment, hearing disorder, cardiac and respiratory dysfunction that impedes training
Orthopedic and neurological disorders that interfere with walking
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Hatsusegawa |
Organization
Saito Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
562-0028
Address
1-1-20 Aominami, Saito, Minou, Osaka
TEL
072-728-7770
hatsusegawa_hhtk@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Hatsusegawa |
Organization
Saito Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
562-0028
Address
1-1-20 Aominami, Saito, Minou, Osaka
TEL
072-728-7770
Homepage URL
hatsusegawa_hhtk@yahoo.co.jp
Sponsor or person
Institute
Saito Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kofu jonan hospital
Rakusai shimizu hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Saito Rehabilitation Hospital
Address
1-1-20 Aominami, Saito, Minou, Osaka
Tel
072-728-7770
office@saito-rh.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R5-030
Org. issuing International ID_1
Kofu jonan hospital education committee
Study ID_2
23-15
Org. issuing International ID_2
Rakusai shimizu hospital
IND to MHLW
Institutions
Institutions
医療法人せいわ会 彩都リハビリテーション病院（大阪府）
甲府城南病院（山梨県）
医療法人清仁会 洛西シミズ病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048643
| 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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| Registered date | File name |
