UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049582 |
|---|---|
| Receipt number | R000056458 |
| Scientific Title | Effectiveness of gait training with walking supportive robot on hemiplegic stroke patients: a crossover study of gait improvement |
| Date of disclosure of the study information | 2022/11/22 |
| Last modified on | 2022/11/22 13:37:58 |
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Basic information
Public title
Effectiveness of gait training with walking supportive robot on hemiplegic stroke patients: a crossover study of gait improvement
Acronym
Effectiveness of gait training with walking supportive robot
Scientific Title
Effectiveness of gait training with walking supportive robot on hemiplegic stroke patients: a crossover study of gait improvement
Scientific Title:Acronym
Effectiveness of gait training with walking supportive robot
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 effects of robotic-assisted gait training to knee joint motion during walking on hemiplegic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of 10m walking test with maximum speed before and after of walking practice
Key secondary outcomes
6-min walking distance
Gait analysis index (3D motion analysis, surface electromyography analysis)
Knee joint extensor muscle strength
Balance ability (Berg Balance Scale, Mini-Balance Evaluation-Systems Test)
Knee joint kinematic data using robotic-assisted walking
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
gait training with orthobot: assistive robot for walking learning (8 sessions, 20 minutes/session)
Interventions/Control_2
conventional gait training (8 sessions, 20 minutes/session)
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
First stroke and at least 6 months since single unilateral stroke onset
Gait ability is 4 or more in Functional Ambulation Category
Key exclusion criteria
Severe cognitive disorders or higher brain dysfunction
Respiratory, cardiac, urologic and digestive dysfunction that impedes training
Neuromuscular or joint diseases affecting gait
At resting heart beat 140 times / min or more, diastolic blood pressure of 120 mmHg or more, or systolic blood pressure of 200 mmHg or more
Patients who received brain stimulation therapy (rTMS, TDCS), robotic-assisted training, or Botulinum toxin therapy within 3 months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Chujo |
Organization
Kansai Medical University Hospital
Division name
Department of Rehabilitation
Zip code
573-1191
Address
2-3-1, Shinmachi, Hirakata city, Osaka
TEL
+81-72-804-0101
chujoyut@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Chujo |
Organization
Kansai Medical University Hospital
Division name
Department of Rehabilitation
Zip code
573-1191
Address
2-3-1, Shinmachi, Hirakata city, Osaka
TEL
+81-72-804-0101
Homepage URL
chujoyut@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kansai Medical University Center for Ethical Review
Address
2-5-1 Shinmachi, Hirakata city, Osaka
Tel
+81-72-804-0101
rinriirb@hirakata.kmu.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
| 2022 | Year | 11 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 11 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056458
