UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050861 |
|---|---|
| Receipt number | R000057963 |
| Scientific Title | Effects of gait practice using a robotic ankle foot orthosis for convalescent stroke patients. |
| Date of disclosure of the study information | 2023/04/25 |
| Last modified on | 2026/07/01 17:21:48 |
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Basic information
Public title
Effects of gait practice using a robotic ankle foot orthosis for convalescent stroke patients.
Acronym
Effects of a Robotic ankle foot Orthosis on Gait Practice.
Scientific Title
Effects of gait practice using a robotic ankle foot orthosis for convalescent stroke patients.
Scientific Title:Acronym
Effects of a Robotic ankle foot Orthosis on Gait Practice.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of gait practice using a robotic ankle foot orthosis for convalescent stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10-meter Walk Test
6-minute Walk Test
Gait Assessment and Intervention Tool
Joint angles during walking
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
In the robotic group, the patient will receive 20-minute gait training with a robotic ankle foot orthosis 10 times in two weeks.
Interventions/Control_2
In the walking group, the patient will receive 20-minute gait training without robotic ankle foot orthosis 10 times in two weeks.
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
First stroke with hemiplegia who admitted to Affiliated hospital of Nagoya City Rehabilitation Center between April 2023 and March 2025, who have had a stroke for at least 1 month but less than 6 months since the onset of the stroke.
Key exclusion criteria
Severe sensory impairment.
Patient who cannot understand the research and instructions owing to the aphasia or the cognitive impairments.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Kaito |
| Middle name | |
| Last name | Toda |
Organization
Nagoya City University Rehabilitation Hospital
Division name
Division of Physical Therapy, Department of Rehabilitation Medicine
Zip code
467-8604
Address
1-2,Mikanyama,Yatomi-cho,Mizuhoku,Nagoya,Japan
TEL
052-680-8123
egmainnx0710@gmail.com
Public contact
Name of contact person
| 1st name | Kaito |
| Middle name | |
| Last name | Toda |
Organization
Nagoya City University Rehabilitation Hospital
Division name
Division of Physical Therapy, Department of Rehabilitation Medicine
Zip code
467-8604
Address
1-2,Mikanyama,Yatomi-cho,Mizuhoku,Nagoya,Japan
TEL
052-680-8123
Homepage URL
egmainnx0710@gmail.com
Sponsor or person
Institute
Nagoya City University Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Rehabilitation Agency
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
Nagoya City University Ethics Review Committee
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 25 | 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
11
Results
With regard to walking speed, the improvement in the between-group comparison of the change (delta) was greater in the control group (p = 0.02). On the other hand, in the gait assessment, although the between-group comparison using an analysis of covariance with pre-intervention values as a covariate did not yield a statistically significant difference, the effect size was large (biased eta-squared = 0.26), and the robot group showed better results.
Results date posted
| 2026 | Year | 07 | Month | 01 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057963
