Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062476) titled 'Effects of Electrical Stimulation on Muscle Activity and Dynamic Balance in Individuals with a History of Ankle Sprain' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Tohoku University

Condition: Condition - History of ankle sprain Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to investigate the immediate effects of neuromuscular electrical stimulation (NMES) applied to the tibialis anterior, compared with sham stimulation, on neuromuscular excitation of the tibialis anterior during muscle contraction and postural control assessed by a clinical balance test in individuals with a history of ankle sprain. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Surface electrodes will be placed over the proximal and distal portions of the tibialis anterior muscle. Neuromuscular electrical stimulation (NMES) will be delivered using a low-frequency electrical stimulation device. Stimulation parameters will be set as follows: biphasic rectangular pulses, frequency of 50 Hz, and pulse duration of 50 us. Stimulation intensity will be adjusted to elicit a muscle contraction corresponding to approximately 20-30% of maximal voluntary isometric contraction, while remaining within a pain-free tolerance level for each participant. The intervention will be applied for 10 minutes using a 5-second on / 15-second off duty cycle (30 cycles in total). Interventions/Control_2 - As a sham condition, transcutaneous electrical nerve stimulation (TENS) will be applied. Electrode placement will be identical to that used in the NMES condition, over the proximal and distal portions of the tibialis anterior muscle. Stimulation will be delivered using biphasic rectangular pulses at a frequency of 100 Hz with a pulse duration of 10 us. The stimulation intensity will be set at a level that elicits a mild sensory perception (tingling sensation) without producing any visible muscle contraction. The stimulation will be applied continuously for 10 minutes.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Participants who meet all of the following criteria will be included: 1. Adults aged 18-29 years who can provide written informed consent 2. Engaging in sports activity at least three times per week (sport level not restricted) 3. Having experienced at least one lateral ankle sprain (involving the anterior talofibular, calcaneofibular, or posterior talofibular ligament) within the past 12 months 4. Reporting residual subjective instability in the previously injured ankle 5. Having a history of ankle sprain diagnosed by a physician or confirmed by a physical therapist based on orthopedic clinical tests 6. No musculoskeletal or neurological disorders within the past 6 months other than ankle sprain Key exclusion criteria - Participants meeting any of the following exclusion criteria will be excluded: 1. History of lower limb surgery or fracture 2. Presence of implanted medical devices such as a pacemaker 3. Pregnancy 4. Malignancy, acute inflammation, or apparent neurological disorder 5. Individuals judged as unsuitable for participation by a physician or physical therapist 6. Acute phase following ankle sprain in which participation in the intervention and measurements may pose a risk to health Target Size - 35

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 16 Day Date of IRB - 2026 Year 06 Month 16 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071051

Disclaimer: Curated by HT Syndication.