UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036521 |
|---|---|
| Receipt number | R000041610 |
| Scientific Title | The combinational effect of intrinsic foot muscle training and electrical stimulation therapy for improving balance in older people |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2026/06/03 15:56:05 |
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Basic information
Public title
The combinational effect of intrinsic foot muscle training and electrical stimulation therapy for improving balance in older people
Acronym
The combinational effect of intrinsic foot muscle training and electrical stimulation therapy for improving balance in older people
Scientific Title
The combinational effect of intrinsic foot muscle training and electrical stimulation therapy for improving balance in older people
Scientific Title:Acronym
The combinational effect of intrinsic foot muscle training and electrical stimulation therapy for improving balance in older people
Region
| Japan |
Condition
Condition
older people
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the combinational effect of intrinsic foot muscle training and electrical stimulation therapy for improving balance in older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional reach test, Timed up and Go test
Key secondary outcomes
Toe grip strength
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intrinsic foot muscle training
Interventions/Control_2
Combination of intrinsic foot muscle training and electrical stimulation therapy
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
No experience of intrinsic foot muscle training.
Key exclusion criteria
History of foot and ankle surgery, and neurologic disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Okamura |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuencho, MIhara City, Hiroshima
TEL
0848-60-1225
k-okamura@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Okamura |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuencho, MIhara City, Hiroshima
TEL
0848-60-1225
Homepage URL
k-okamura@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
FRANCE BED MEDICAL HOME CARE RESEARCH SUBSIDY PUBLIC INTEREST INCORPORATED FOUNDATIONS
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1 Gakuencho, MIhara City, Hiroshima
Tel
0848-60-1225
k-okamura@pu-hiroshima.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
| 2019 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0268003320303065?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0268003320303065?via%3Dihub
Number of participants that the trial has enrolled
24
Results
The main finding of this study was that the intrinsic foot muscles strengthening exercises with electromyographic biofeedback increased TFS on the nondominant side in older adults. However, the results of the timed up-and-go and functional reach tests did not change.
Results date posted
| 2026 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly residents of the community who participate in day care rehabilitation services
Participant flow
We assessed 24 individuals for eligibility and excluded one because of dementia. We then allocated the remaining 23 participants randomly to the control or EMG-BF group. One control participant declined to participate in the intervention; thus, 22 individuals underwent the allocated interventions. During the follow-up, there was a loss of three (27%) individuals in the control group and two (18%) in the EMG-BF group.
Adverse events
None
Outcome measures
Functional reach test
Timed up and Go test
Toe grip strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041610
