UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060276 |
|---|---|
| Receipt number | R000068951 |
| Scientific Title | Immediate Effects of Proprioceptive Training and Tactile Stimulation on Balance Performance under Eyes-Closed Conditions: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2026/01/06 21:44:19 |
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Basic information
Public title
Immediate Effect of Proprioceptive Training and Tactile Stimulation for Improving Balance during Closed-Eyes Condition: Randomized Controlled Trial
Acronym
IPTTS-EC
Scientific Title
Immediate Effects of Proprioceptive Training and Tactile Stimulation on Balance Performance under Eyes-Closed Conditions: A Randomized Controlled Trial
Scientific Title:Acronym
IPTTS-EC
Region
| Japan |
Condition
Condition
Healthy adults without known neurological, musculoskeletal, or balance disorders
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the immediate effects of proprioceptive training and tactile stimulation on balance performance under eyes-closed conditions in healthy adults, and to explore concurrent changes in cortical activation measured by fNIRS during the balance tasks.
Basic objectives2
Others
Basic objectives -Others
To investigate the immediate effects of sensorimotor manipulations on balance performance and associated cortical activation under experimentally controlled eyes-closed conditions.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Balance performance under eyes-closed conditions, assessed immediately after the intervention using the One-Leg Standing Test (OLST) and the Multi-Directional Reach Test (MDRT).
Key secondary outcomes
Task-related cortical activation, assessed using functional near-infrared spectroscopy (fNIRS) during eyes-closed balance tasks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
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
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group 1 (Unstable surface with plantar tactile stimulation):
Participants performed eyes-closed standing balance tasks on an unstable surface while receiving tactile stimulation through a textured plantar surface placed under the feet. Participants were allowed to hold a handrail for safety purposes. The protocol consisted of a single-session (immediate). Balance tasks were performed while cortical activation was recorded using fNIRS. Balance outcomes (OLST and MDRT) were assessed immediately after the session.
Interventions/Control_2
Group 2 (Unstable surface without plantar tactile stimulation):
Participants performed eyes-closed standing balance tasks on an unstable surface without additional plantar tactile stimulation (non-textured surface). Participants were allowed to hold a handrail for safety purposes. The protocol consisted of a single session (immediate). Balance tasks were performed while cortical activation was recorded using fNIRS. Balance outcomes (OLST and MDRT) were assessed immediately after the session.
Interventions/Control_3
Group 3 (Stable surface with plantar tactile stimulation):
Participants performed eyes-closed standing balance tasks on a stable surface while receiving tactile stimulation through a textured plantar surface placed under the feet. Participants were allowed to hold a handrail for safety purposes. The protocol consisted of a single-session (immediate). Balance tasks were performed while cortical activation was recorded using fNIRS. Balance outcomes (OLST and MDRT) were assessed immediately after the session.
Interventions/Control_4
Group 4 (Stable surface without plantar tactile stimulation):
Participants performed eyes-closed standing balance tasks on a stable surface without additional plantar tactile stimulation (non-textured surface). Participants were allowed to hold a handrail for safety purposes. The protocol consisted of a single-session (immediate). Balance tasks were performed while cortical activation was recorded using fNIRS. Balance outcomes (OLST and MDRT) were assessed immediately after the session.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were: age between 18 and 50 years; normal or corrected-to-normal vision; intact sensorimotor and proprioceptive function; and ability to provide voluntary informed consent.
Key exclusion criteria
Exclusion criteria included a history of neurological, vestibular, or acute musculoskeletal disorders that could affect balance performance, as well as any communication impairments preventing task understanding.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Raden Galuh Gurmadi |
| Middle name | |
| Last name | Gandawidura |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
+81-80-1989-2399
galuhgur@gmail.com
Public contact
Name of contact person
| 1st name | Raden Galuh Gurmadi |
| Middle name | |
| Last name | Gandawidura |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
+81-80-1989-2399
Homepage URL
galuhgur@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Self-funded / No external funding
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
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
a-rinri@jmj.tmu.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
| 2026 | Year | 01 | Month | 06 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | 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
| 2026 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068951
