Clinical Trial: Effects of Six Weeks of Balance Training With or Without Proximal-Shank Blood Flow Restriction on Pain, Ankle Muscle Strength, Perceived Instability, Dynamic Balance, Proprioception, and Functional Performance in Athletes With Chronic Ankle Instability: A Randomized Controlled Trial (Japan)

Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059860) titled 'Effect of 6 Weeks of Balance Training With or Without Blood Flow Restriction on Pain, Muscle Strength, and Functional Performance in Athletes With Chronic Ankle Instability' on Nov. 30.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Shahrood University of Technology

Condition: Condition - Functional Ankle Instability Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine whether adding proximal-shabk blood flow restriction (BFR) to a 6-week progressive balance training program results in greater reductions in pain and perceived ankle instability, as well as larger improvements in dynamic postural control, compared to the same balance training program performed without BFR in athletes with chronic ankle instability (CAI). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 6 weeks, 3 sessions/week, 30-45 min per session. Identical progressive unilateral balance exercises (single-leg stance, squats, hops, tuck jumps, ball tasks, unstable surfaces, eyes closed progressions) performed on the involved limb with a 10-cm wide pneumatic cuff applied to the proximal shank at 70-80% limb occlusion pressure (LOP). Cuff inflated continuously during the exercise block (15-20 min) and deflated during warm-up and cool-down. Interventions/Control_2 - Exactly the same 6-week, 3 sessions/week progressive unilateral balance training program as the experimental group (identical exercises, volume, intensity, and progression), but performed without any cuff application.

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - Male recreational or competitive athlete At least two episodes of giving way at the ankle in the past 6 months Unilateral chronic functional ankle instability Key exclusion criteria - Key Exclusion Criteria

Bilateral chronic ankle instability Mechanical ankle instability (positive anterior drawer or talar tilt test >1+ on clinical examination) Acute ankle sprain or lower-extremity injury within the previous 3 months History of fracture or surgery in the lower extremity Neurological, vestibular, or severe visual impairment that affects balance Diagnosed deep vein thrombosis, peripheral vascular disease, or any absolute contraindication to blood flow restriction Hypertension (resting blood pressure >140/90 mmHg) Current participation in a formal ankle rehabilitation or strength-training program Inability or unwillingness to adhere to the 6-week supervised training protocol (3 sessions/week) Any medical condition that, in the opinion of the investigator, would make BFR or intensive balance training unsafe Female sex (study limited to male participants only) Target Size - 45

Recruitment Status: Recruitment status - Suspended Date of protocol fixation - 2025 Year 03 Month 12 Day Date of IRB - 2025 Year 10 Month 10 Day Anticipated trial start date - 2025 Year 11 Month 03 Day Last follow-up date - 2025 Year 12 Month 07 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068450

Disclaimer: Curated by HT Syndication.