UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045121 |
|---|---|
| Receipt number | R000051381 |
| Scientific Title | A study of assistive methods for ankle joint to improve walking ability in older adults. |
| Date of disclosure of the study information | 2021/08/11 |
| Last modified on | 2022/02/02 16:59:22 |
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Basic information
Public title
A study of assistive methods for ankle joint to improve walking ability in older adults.
Acronym
Assistive methods for ankle joint to improve walking ability.
Scientific Title
A study of assistive methods for ankle joint to improve walking ability in older adults.
Scientific Title:Acronym
Assistive methods for ankle joint to improve walking ability.
Region
| Japan |
Condition
Condition
Community-dwelling older adults who attend the day-care center
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the adaptation of gait performance by robotic assistance for the ankle joint in community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in temporospatial gait parameters before and after the gait training using the ankle robot.
Key secondary outcomes
Muscle strength of lower limb (hip abduction, knee extension, ankle plantar-flextion)
Balance (Berg Balance Scale)
Number of falls (past 3 months)
Easy to walk (Numerical Rating Scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treadmill walking with ankle robot assist (continuously)
20 minutes, per week, for 3 months
Interventions/Control_2
Treadmill walking with ankle robot assist (decline)
20 minutes, per week, for 3 months
Interventions/Control_3
Treadmill walking (conventional)
20 minutes, per week, for 3 months
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
1) Aged 65 years and older
2) Independently walking indoors without a walking aid or with supervision
Key exclusion criteria
1) History of administration or operation past 3 months
2) Pain affecting the walking
3) Unable to understand instructions due to cognitive dysfunction
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Wakida |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89 Uyamahigashimachi Hirakata city, Osaka
TEL
072-856-2318
wakidam@makino.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Wakida |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89 Uyamahigashimachi Hirakata city, Osaka
TEL
072-856-2318
Homepage URL
wakidam@makino.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
072-804-2440
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
| 2021 | Year | 08 | Month | 11 | 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
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 12 | 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
Management information
Registered date
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2022 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051381
| Research Plan | |
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| 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 |
