UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056451 |
|---|---|
| Receipt number | R000064508 |
| Scientific Title | Exploration of quantitative parameters using a sitting balance assessment and training system, and study of their validity and feasibility. |
| Date of disclosure of the study information | 2024/12/13 |
| Last modified on | 2024/12/13 17:27:24 |
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Basic information
Public title
Exploration of quantitative parameters using a sitting balance assessment and training system, and study of their validity and feasibility.
Acronym
Exploration of quantitative parameters using a sitting balance assessment and training system, and study of their validity and feasibility.
Scientific Title
Exploration of quantitative parameters using a sitting balance assessment and training system, and study of their validity and feasibility.
Scientific Title:Acronym
Exploration of quantitative parameters using a sitting balance assessment and training system, and study of their validity and feasibility.
Region
| Japan |
Condition
Condition
Healthy subjects
Rehabilitation subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an assessment and training system that can quantify sitting balance, and to verify its validity and practicality through measurements of healthy and rehabilitative subjects.
Basic objectives2
Others
Basic objectives -Others
Feasibility, safety, efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic parameters (distance, speed, range of movement, etc.) of the COP.
Questionnaire-based subjective assessment based on the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) and other methods.
Key secondary outcomes
Trunk Impairment Scale (TIS), Function In Sitting Test (FIST), Brunel Balance Assessment (BBA), Functional reach test in sitting position, etc.
Kinematic indicators (posture and hand position) of the upper extremities and trunk during various movements in a sitting position.
Subjective assessments of entertainment value and potential for continued use using the Numerical Rating Scale (NRS).
Age, gender, body mass index.
Basic information obtained during normal medical treatment and rehabilitation for rehabilitation subjects.
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Sitting exercises at the level of activities of daily living.
Questionnaire on feasibility.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy subjects
People who have no history of brain disease, neurological or muscular disease, and who have given informed consent for this study.
2)Rehabilitation subjects
Patients who are currently in hospital or attending outpatient rehabilitation and who have given informed consent for this study.
Key exclusion criteria
1)Healthy subjects
People with a history of brain disease or neurological/muscular disease.
People with orthopedic disorders that currently interfere with exercise.
2)Rehabilitation subjects
Patients whose general condition is unstable and who may experience sudden changes.
Patients who have difficulty following instructions when performing tasks due to impaired consciousness or cognitive function.
Patients who currently have orthopedic conditions that interfere with movement.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2167
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Ota |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9000
Homepage URL
hiro0527@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SPEED Corporation, SMK Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98 Dengakugakubo, Kutukake-cho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2024 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | 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
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064508
