UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055206 |
|---|---|
| Receipt number | R000063086 |
| Scientific Title | Cross-education effects following balance training of the unilateral lower extremity. |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2025/11/26 12:19:07 |
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Basic information
Public title
Verification of the transfer effect of one-legged balance training to the non-training side.
Acronym
Verification of the transition effect of one-legged balance training
Scientific Title
Cross-education effects following balance training of the unilateral lower extremity.
Scientific Title:Acronym
Cross-education effects following balance training of the unilateral lower extremity.
Region
| Japan |
Condition
Condition
old people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of Cross-Education Effects in Balance Training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of gravity sway during one-leg standing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
One leg standing training with the dominant leg for 30 seconds x 10 sets
Interventions/Control_2
Resting chair position for 15 min.
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
| 19 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The principal investigator will explain the outline of the experiment to the participants, who must be affiliated with Tohoku University or its graduate school and have voluntarily volunteered to participate in the experiment.
Key exclusion criteria
Excluded if any of the following conditions are met: neurological or psychiatric disease, taking neuro-active drugs, or injury or fracture of the lower extremity.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirose |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare, Department of Health Sciences, Physical Therapy, Master's course, 1st year
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
hpm24001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirose |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare, Department of Health Sciences, Physical Therapy,
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
Homepage URL
hpm24001@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Hirose Yoshiki
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
hpm24001@nuhw.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 | 08 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2025 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063086
