UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052504 |
|---|---|
| Receipt number | R000059916 |
| Scientific Title | Effect of repetitive calf raises with plantar flexion assist device on gait function in older adults |
| Date of disclosure of the study information | 2023/10/15 |
| Last modified on | 2023/10/15 19:52:11 |
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Basic information
Public title
Effect of repetitive calf raises with plantar flexion assist device on gait function in older adults
Acronym
Effect of repetitive calf raises with plantar flexion assist device on gait
Scientific Title
Effect of repetitive calf raises with plantar flexion assist device on gait function in older adults
Scientific Title:Acronym
Effect of repetitive calf raises with plantar flexion assist device on gait
Region
| Japan |
Condition
Condition
healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of repetitive calf raises with plantar flexion assist device on ankle plantar flexion function and gait function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Gait parameter (gait speed, cadence, step length)
- Plantarflexion muscle strength
- Plantarflexion movement velocity
- Ankle joint range of motion
Key secondary outcomes
- Height, Body weight
- Balance function (Timed Up & Go Test, Functional Reach Test)
- Knee extension muscle strength
- Knee extension movement velocity
- Frailty scale (J-CHS score)
- Physical Activity (IPAQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
intervention group (calf raises with plantar flexion assist device)
10 weeks
Interventions/Control_2
control group (daily life as usual)
10 weeks
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Ability to walk 10m without physical assistance or gait aid.
- Ability to perform calf-raising exercises.
Key exclusion criteria
- Patients with dementia
- Patients with moderate or severe respiratory disease
- Patients with moderate or severe cardiovascular disease
- Persons with significantly limited motion of the ankle joint
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka, Japan.
TEL
072-950-2111
iwata@omu.ac.jp
Public contact
Name of contact person
| 1st name | Atsuki |
| Middle name | |
| Last name | Kanayama |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka, Japan.
TEL
072-950-2111
Homepage URL
kanayama@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Akira IWATA
Funding Source
Organization
Mizuno Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mizuno Corporation
Address
1-12-35 Nankokita, Suminoe-ku, Osaka-city, Osaka, Japan.
Tel
06-6614-8436
hnagao@mizuno.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 15 | 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
| 2023 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059916
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
