UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056123 |
|---|---|
| Receipt number | R000064129 |
| Scientific Title | A feasibility study of balance exercise using a care lift. |
| Date of disclosure of the study information | 2024/11/12 |
| Last modified on | 2024/11/12 02:11:46 |
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Basic information
Public title
A feasibility study of balance exercise using a care lift.
Acronym
Balance exercise using a care lift.
Scientific Title
A feasibility study of balance exercise using a care lift.
Scientific Title:Acronym
Balance exercise using a care lift.
Region
| Japan |
Condition
Condition
Patients with imbalance
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the feasibility of balance exercises using a nursing lift.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of balance exercises with a care lift for 3 weeks
Key secondary outcomes
Daily rehabilitation contents, SIDE (Standing test for Imbalance and DisEquilibrium), BBS (Berg Balance Scale), SPPB (Short Physical Performance Battery), TUG (Timed Up & Go Test), FRT (Functional Reach Test), gait speed, Quadriceps force, grip power, force plate, functional base of support, FIM (Functional Independence Measure), FAC (Functional Ambulation Categories), and Stroke Impairment Assessment Set
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional balance exercises with a care lift.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who can stand with open legs but cannot stand on one leg for 30 seconds on either side.
2) Height 170cm or less
Key exclusion criteria
1) Patients who are unable to adequately follow the therapist's instructions due to cognitive decline, higher functional impairment, etc.
2) Patients who are expected to be discharged within 3 weeks
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
hkagaya2@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
Homepage URL
hkagaya2@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
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
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi
Tel
0562-46-2311
yaday@ncgg.go.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 | 11 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | 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 | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064129
