UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055577 |
|---|---|
| Receipt number | R000063508 |
| Scientific Title | Development of basic technology for the creation of tele-rehabilitation services based on medical evidence |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2026/03/28 23:45:45 |
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Basic information
Public title
Development of basic technology for the creation of tele-rehabilitation services based on medical evidence
Acronym
Development of basic technology for the creation of tele-rehabilitation services
Scientific Title
Development of basic technology for the creation of tele-rehabilitation services based on medical evidence
Scientific Title:Acronym
Development of basic technology for the creation of tele-rehabilitation services
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating ways to solve abnormal gait using the RE-Gait walking aid device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of hip, knee, ankle and other joint angles during walking before and after intervention with the RE-Gait walking aid
Key secondary outcomes
Walking speed, stride length, foot pressure distribution during walking, load balance, foot pressure center, acceleration, etc.
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
| Other |
Interventions/Control_1
Use of the RE-Gait walking aid
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a history of stroke who can walk independently for at least 15 minutes.
Key exclusion criteria
Those who cannot walk independently for more than 15 minutes
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Youhei |
| Middle name | |
| Last name | Yanai |
Organization
Ube Nishi Rehabilitation Hospital
Division name
Rehabilitation Department
Zip code
759-0202
Address
797 Oaza Okinodan, Ube City, Yamaguchi Prefecture
TEL
0836452111
ubenishireha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Youhei |
| Middle name | |
| Last name | Yanai |
Organization
Ube Nishi Rehabilitation Hospital
Division name
Rehabilitation Department
Zip code
759-0202
Address
797 Oaza Okinodan, Ube City, Yamaguchi Prefecture
TEL
0836452111
Homepage URL
ubenishireha@yahoo.co.jp
Sponsor or person
Institute
Ube Nishi Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Ube Nishi Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
SPACE BIO LABORATORIES, Inc.
Name of secondary funder(s)
Yamaguchi prefecture
IRB Contact (For public release)
Organization
Ube Nishi Rehabilitation Hospital Ethics Review Committee
Address
797 Oaza Okinodan, Ube City, Yamaguchi Prefecture
Tel
0836452111
ubenishireha@yahoo.co.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
宇部西リハビリテーション病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
15
Results
1: In the comparison of each indicator before and after the RE-Gait walking aid intervention in this case, no statistically significant differences were observed.
2: A paired t-test was used to compare FIM walking scores before and after the robot intervention. The results showed a significant improvement after the intervention (p=0.028).
A paired t-test was used to compare SIAS scores before and after the robot intervention, but no significant difference was observed (p=0.15).
Results date posted
| 2026 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
1: Walking speed, stride length, foot pressure during walking, acceleration, joint angles (hip, knee, ankle, etc.), and surface electromyography of lower limb muscles
2: FIM: Functional Independence Measure SIAS: Stroke Impairment Assessment Scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063508
