Preventive effect of low level laser for joint position sense deterioration induced by muscle fatigue

JRCT ID: jRCTs062230104

Registered date:07/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult volunteers
• Date of first enrollment: 13/06/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Laser irradiation to leg using low level laser equipment (sheep) or placebo device.

Outcome(s)

• Primary Outcome: The differences of the replication errors for joint position sense between low level laser group and placebo device group.

Secondary Outcome

The differences of the replication errors for joint position sense between dominance leg and non-dominance legs in low level laser group.
Muscle activity in the leg surface electromyography.
Rating of perceived exertion (Borg scale).
Visual Analog Scale (VAS) for fatigure.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1. Age at the time of consent is between 18 and 65 years old.
2. Informed consent has been obtained and sufficient understanding of the study has been obtained.

Exclude criteria

1. History of previous treatment for leg or ankle injuries and disorders.
2. Participants with mental illness, convulsive attack, seizure disorder, heart disease, cardiac pacemaker, or skin disorder at the laser irradiation site.
3. History of serious side effect to low level laser therapy.
4. Participants who meet the contraindication of the laser equipment.
5. Women who are pregnant or suspected to be pregnant, or who desire to bear children.
6. Participants who have participated or are willing to participate in other clinical studies.
7. Participants who were judged as having the possibility of interruption of specific assessment of the clinical reserach protocol.
8. Researchers who are directly involved in this study or other clinical studies, or employees of medical facility for clinical trial implementation, or their family.

Related Information

• Primary Sponsor: Adachi Nobuo
• Source(s) of Monetary Support: Unitac Corporation