UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016529 |
|---|---|
| Receipt number | R000019191 |
| Scientific Title | The effects of a non-powered swing-assist robotic orthosis on gait; Within-subject study in hemiparetic stroke patients. |
| Date of disclosure of the study information | 2015/02/13 |
| Last modified on | 2018/12/06 17:14:21 |
* 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
The effects of a non-powered swing-assist robotic orthosis on gait; Within-subject study in hemiparetic stroke patients.
Acronym
The effects of a non-powered swing-assist robotic orthosis on gait in hemiparetic stroke patients.
Scientific Title
The effects of a non-powered swing-assist robotic orthosis on gait; Within-subject study in hemiparetic stroke patients.
Scientific Title:Acronym
The effects of a non-powered swing-assist robotic orthosis on gait in hemiparetic stroke patients.
Region
| Japan |
Condition
Condition
hemiparetic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a non-powered swing-assist robotic orthosis on gait in hemiparetic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m walking test
Three-minute walking test
Gait analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
with non-powered swing-assist orthosis
Interventions/Control_2
without non-powered swing-assist orthosis
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
1.First-ever hemiparetic stroke
2.Patients with hemiplegic gait
3.Able to walk for 3 min without assistance.
4.Mini-Mental State Examination >= 22
5.Consent to participate in the study
Key exclusion criteria
1.Musculoskeletal disorders in the lower limbs
2.Other neurological diseases
3.Patients who need exercise restriction due to cardiac and/or pulmonary diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Inoue |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Division of Physical therapy
Zip code
Address
4-1-1 Yatsu,Narashino-shi,Chiba
TEL
047-453-9010
s.inoue@wanreha.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Inoue |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Division of Physical therapy
Zip code
Address
4-1-1 Yatsu,Narashino-shi,Chiba
TEL
047-453-9010
Homepage URL
s.inoue@wanreha.net
Sponsor or person
Institute
Tokyo Bay 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
Department of Rehabilitation Medicine, Keio University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京湾岸リハビリテーション病院(千葉県)
Tokyo Bay Rehabilitation Hospital(Chiba)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 13 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 07 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019191
