UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033556 |
|---|---|
| Receipt number | R000038265 |
| Scientific Title | Verification of effectiveness using gait exercise assist robot in patients with hemiplegia |
| Date of disclosure of the study information | 2018/07/31 |
| Last modified on | 2025/02/02 09:12:15 |
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Basic information
Public title
Verification of effectiveness using gait exercise assist robot in patients with hemiplegia
Acronym
Study on gait exercise assist robot in patients with hemiplegia
Scientific Title
Verification of effectiveness using gait exercise assist robot in patients with hemiplegia
Scientific Title:Acronym
Study on gait exercise assist robot in patients with hemiplegia
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effectiveness with gait exercise assist robot in severe hemiplegic patients who need knee-ankle-foot orthosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement in efficiency of FIM-walk
Key secondary outcomes
Stroke Impairment Assessment Set (SIAS),
gait velocity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The interventions for the subjects are the training with gait exercise assist robot (Wel-walk).
The frequency of the interventions for inpatients is 40 minutes a day and five times a week. The maximum period is eight weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with hemiplegia in a rehabilitation ward
The general condition is stable
Standing and walking training is permitted by the doctor.
Patients require the knee-ankle-foot orthosis to stand and walk by the judgement ofthe rehabilitation doctor.
Informed-consent has been obtained
Key exclusion criteria
High-blood pressure (systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 120 mmHg or resting heart rate >= 120/min)
Restricted exercise due to heart function or respiratory function disorder
Hearing or visual impairment
Dementia or severe higher brain dysfunction
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
Tel
0562-46-2311
ik7710@ncgg.go.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
| 2018 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jpts/34/11/34_2022-064/_article/-char/en
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jpts/34/11/34_2022-064/_article/-char/en
Number of participants that the trial has enrolled
16
Results
Nine patients were able to walk 10 m at supervision or independent level.
Seven patients required assistance.
Results date posted
| 2022 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
16 stroke patients as the participants of the study
age 67 years(SD:13)
female n=9
Participant flow
Written informed consent was obtained from each participant or from the participant's family prior to participation.
Adverse events
no
Outcome measures
10m walking assistance
SIAS(Stroke Impairment Assessment Set)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2018 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038265
