UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061504 |
|---|---|
| Receipt number | R000070377 |
| Scientific Title | Comparative Effects of Low-Level versus High-Intensity Laser Therapy on Neuromuscular Function and Balance in Healthy Older Adults: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/09 |
| Last modified on | 2026/05/09 22:05:05 |
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Basic information
Public title
Comparative Effects of Low-Level and High-Intensity Laser Therapy on Neuromuscular Function and Balance in Healthy Older Adults: A Randomized Controlled Trial
Acronym
LLLT-HILT Balance Trial
Scientific Title
Comparative Effects of Low-Level versus High-Intensity Laser Therapy on Neuromuscular Function and Balance in Healthy Older Adults: A Randomized Controlled Trial
Scientific Title:Acronym
LLLT-HILT-NFB Trial
Region
| Asia(except Japan) |
Condition
Condition
Healthy older adults with age-related lower-limb neuromuscular and balance function decline
Classification by specialty
| Geriatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of high-energy laser therapy and low-energy laser therapy on pain, knee-related symptoms, peri-knee muscle stiffness, neuromuscular co-activation during squatting and standing, and static and dynamic balance performance in healthy older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Static balance performance measured by the Balance Error Scoring System (BESS) at baseline and immediately after the 12-week intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High energy laser therapy group: Participants received high energy laser therapy with the LMD LT 30 laser therapy device. The treatment was delivered at a wavelength of 1064 nm with an output power of 5 W. Each treatment session lasted 30 minutes, consisting of 10 minutes of pulsed irradiation followed by 20 minutes of continuous irradiation. Treatment was provided three times per week for 12 weeks. The laser was applied with a slow scanning technique over an area of approximately 8 square centimeters around the knee, including the anteromedial, anterolateral, medial, and lateral knee regions, as well as the joint line. The total energy delivered in each session was 9000 J, with an energy density of 1125 J per square centimeter.
Interventions/Control_2
Low energy laser therapy group: Participants received low energy laser therapy using the same scanning method and treatment area as the high energy laser therapy group. The treatment was delivered at a wavelength of 830 nm with a peak power output of 400 mW. Each treatment session lasted 30 minutes, consisting of 10 minutes of pulsed irradiation followed by 20 minutes of continuous irradiation. Treatment was provided three times per week for 12 weeks. The laser was applied over the same area of approximately 8 square centimeters around the knee. The total energy delivered in each session was 720 J, with an energy density of 90 J per square centimeter.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy older adults aged 65 years or above.
2. Able to understand the study procedures and follow instructions during testing and intervention.
3. Able to complete the required assessments and laser intervention.
4. No diagnosed lower-limb musculoskeletal disease.
5. Willing to participate and provide written informed consent.
Key exclusion criteria
1. Diagnosed knee osteoarthritis or other knee joint disorders.
2. Lower-limb musculoskeletal diseases or injuries that could affect muscle stiffness, balance, or functional movement.
3. History of lower-limb surgery, fracture, or severe trauma.
4. Cognitive impairment, behavioral problems, or communication difficulties that prevented cooperation with the study procedures.
5. Neurological disorders or other conditions that could substantially affect balance or lower-limb neuromuscular function.
6. Contraindications to laser therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Lele |
| Middle name | |
| Last name | Chang |
Organization
Jeonbuk National University
Division name
Integrative Exercise Physiology Laboratory, Department of Physical Education
Zip code
54896
Address
Integrative Exercise Physiology Laboratory, Department of Physical Education, Jeonbuk National University, Jeonju, South Korea
TEL
+8618669721890
changleler@outlook.com
Public contact
Name of contact person
| 1st name | Lele |
| Middle name | |
| Last name | Chang |
Organization
Jeonbuk National University
Division name
Integrative Exercise Physiology Laboratory, Department of Physical Education
Zip code
54896
Address
Integrative Exercise Physiology Laboratory, Department of Physical Education, Jeonbuk National Unive
TEL
+8618669721890
Homepage URL
changleler@outlook.com
Sponsor or person
Institute
Integrative Exercise Physiology Laboratory, Department of Physical Education, Jeonbuk National University,
Institute
Department
Personal name
Funding Source
Organization
Science and Technology Innovation Project of the Qingdao High-tech Industrial Development Zone Administrative Committee
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Qufu Normal University
Address
No. 57, Jingxuan West Road, Qufu City, Shandong Province
Tel
+8613639443653
liu2578794@gmail.com
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
Qufu Normal University (Qufu)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
50
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
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 15 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2026 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070377
