UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041466 |
|---|---|
| Receipt number | R000047317 |
| Scientific Title | Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait |
| Date of disclosure of the study information | 2020/08/20 |
| Last modified on | 2022/04/05 13:13:14 |
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Basic information
Public title
Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Acronym
Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Scientific Title
Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Scientific Title:Acronym
Walking rehabilitation using a supporting device for hip joint movement:effects on patients with hemiplegic gait
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Walking rehabilitation using a supporting device for hip joint movement effects on patients with hemiplegic gait
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait Assessment and Intervention Tool
Key secondary outcomes
electromyography
Brunstrom stage
modified Ashworth scale
Functional Ambulation Categories
10m walking test
sensory test
knee extension muscle strength test
one leg standing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform rehabilitation for 2 weeks using a walking assist robot
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Walkable convalescent stroke patients
Key exclusion criteria
consciousness disturbance advanced dementia or communicative difficulties
Cause other neuromuscular complications
Undergo surgical treatments
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Egashira |
Organization
Suita Municipal Hospital
Division name
Department of Rehabilitation medicine
Zip code
564-8567
Address
5-7 kishibeshinmachi suita Osaka japan
TEL
06-6387-3311
reha@mhp.suita.osaka.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Suita Municipal Hospital
Division name
Department of Rehabilitation medicine
Zip code
564-8567
Address
5-7 kishibeshinmachi suita Osaka japan
TEL
06-6387-3311
Homepage URL
reha@mhp.suita.osaka.jp
Sponsor or person
Institute
Suita Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Suita Municipal Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suita Municipal Hospital
Address
5-7 kishibeshinmachi suita Osaka japan
Tel
06-6387-3311
kodama7899@mhp.suita.osaka.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | 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 | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047317
