Background and Rationale:
Hallux valgus (HV) is a progressive musculoskeletal deformity characterized by the lateral deviation of the great toe and medial deviation of the first metatarsal. This pathology significantly impairs the first metatarsophalangeal (MTP) joint dynamics, medial longitudinal arch structure, and load-bearing mechanisms. Clinical evidence suggests that HV leads to foot pain, functional limitations, impaired balance, and an increased risk of falls. While various conservative treatments exist, Kinesio Taping (KT) has gained popularity for providing dynamic support without restricting joint range of motion. This study was conducted to evaluate the corrective, functional, and biomechanical efficacy of KT integrated into an exercise program.
Study Design:
This study utilized a prospective, randomized, controlled, and assessor-blinded design. It was conducted in accordance with the Declaration of Helsinki and approved by the local Clinical Research Ethics Committee.
Participant Selection and Randomization:
Symptomatic individuals (VAS score ≥ 3) aged 18-65 with mild-to-moderate HV (HVA 15°-40°, IMA 9°-16°) were recruited from the physical medicine and rehabilitation outpatient clinic. Participants were excluded if they had neuromuscular diseases, previous foot surgery, acute inflammatory conditions, malignancies, or skin lesions in the application area. Randomization was performed using a web-based random sequence generator (random.org), and participants were assigned to groups via sequentially numbered, opaque, sealed envelopes to ensure allocation concealment.
Intervention Protocols:
Kinesio Taping Group (Group 1): Participants received four sessions of specialized KT (Kinesio Tex Gold®) applied once a week by a certified physician. A combined "I" and "X" strip configuration was used. The "I" strip was applied from the medial proximal phalanx to the posterior calcaneus with 50% mechanical correction tension. The "X" strip was applied over the first MTP joint to provide rotational control and support the transverse arch.
Exercise Protocol: Both groups followed a standardized 4-week home exercise program (2 sets of 10 repetitions daily). The protocol included "short foot" exercises, toe spreading, modified heel raises, and isolated toe extensions, supported by visual brochures and exercise diaries.
Control Group (Group 2): Participants performed the same 4-week exercise program without any taping intervention.
Assessment and Data Collection:
Assessments were conducted at baseline and after the 4-week intervention period.
Radiological Assessment: Hallux Valgus Angle (HVA) and Intermetatarsal Angle (IMA) were measured on standard weight-bearing anteroposterior radiographs by a blinded radiologist.
Pedobarographic Analysis: Dynamic gait and static posture analyses were performed using the Zebris® FDM-2 Pressure Analysis System. Data collection included a 10-second static stance and a 20-second barefoot dynamic gait analysis. A blinded physiotherapist processed the data using 3-region (hindfoot, midfoot, forefoot) and 7-region (medial/lateral heel, midfoot, medial/internal/lateral forefoot, and toes) protocols to determine peak maximum force and pressure distribution.
Clinical and Functional Measures: Pain intensity was recorded using the Visual Analog Scale (VAS). Functional status and foot-related quality of life were evaluated using the AOFAS-MTP-IP scale. Functional exercise capacity was measured via the 6-Minute Walk Test (6MWT) in a 10-meter standardized corridor.
Statistical Analysis:
The target sample size was determined as 50 participants (25 per group) based on a power analysis (G\*Power 3.1) to achieve a power of 0.95. Data analysis was performed using R software (v4.4.1). Intragroup and intergroup comparisons were conducted using parametric (Independent and Paired Samples T-tests) or non-parametric tests (Mann-Whitney U and Wilcoxon tests) depending on the normality of data distribution. Statistical significance was set at p \< 0.05.
