UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048231 |
|---|---|
| Receipt number | R000054964 |
| Scientific Title | Verification of Reliability of Hemiplegic Gait Data Measured by Depth Sensor |
| Date of disclosure of the study information | 2022/07/02 |
| Last modified on | 2023/07/05 20:04:24 |
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Basic information
Public title
Verification of Reliability of Hemiplegic Gait Data Measured by Depth Sensor
Acronym
Verification of Reliability of Hemiplegic Gait Data Measured by Depth Sensor
Scientific Title
Verification of Reliability of Hemiplegic Gait Data Measured by Depth Sensor
Scientific Title:Acronym
Verification of Reliability of Hemiplegic Gait Data Measured by Depth Sensor
Region
| Japan |
Condition
Condition
Stroke, brain tumor
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and verify the reliability of gait data calculated by the 3D motion analyzer and Depth Sensor in stroke and brain tumor patients who present with gait disorders.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower limb joint range of motion angle during walking
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke and brain tumor patients
1) Chronic stroke or brain tumor hemiplegia patients who have had a stroke for at least 6 months, 2) Able to walk at least 7 meters (braces or walking aids are allowed), 3) Able to understand verbal instructions, 4) Able to walk for 3 minutes continuously
Normal subjects
1)No history of bone and joint diseases of the lower limbs
2)No history of central nervous system disease
Key exclusion criteria
Stroke and brain tumor patients
1) Patients with diabetic neuropathy, 2) Patients with neurological symptoms in the nonparalytic side of the lower limb, 3) Patients with sensory loss in the distal part of the nonparalytic side of the lower limb, 4) Patients with a weakened or lost Achilles tendon reflex in the nonparalytic side, 5) Patients with history of osteoarticular disease or injury in the lower limb, 6) Patients with cerebellar or brainstem lesions, 7) Patients with symptoms of hemispatial neglect, and with a score of 2 or less in the SIAS (stroke impairment assessment set) visuospatial cognitive test 7) Patients with symptoms of hemispatial neglect and score less than 2 points on the SIAS (stroke impairment assessment set) visuospatial cognition test.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University Graduate School
Division name
Department of Medicine, Graduate School of Limbic Unfreedom Science Subfield
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7338
shibuya.ryosuke.q2@dc.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Shibuya |
Organization
Tohoku University Graduate School
Division name
Department of Medicine, Graduate School of Limbic Unfreedom Science Subfield
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
08016878496
Homepage URL
shibuya.ryosuke.q2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 07 | Month | 02 | 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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gait observation using a 3D motion analyzer and Depth Sensor simultaneously in two groups of healthy subjects and a group of stroke victims will be performed and compared.
Management information
Registered date
| 2022 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054964
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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