- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07589829
The Effects of Kinesio Taping on Hallux Valgus
The Effects of Kinesio Taping on Hallux Valgus Angle, Plantar Pressure Measurements, and Foot-Related Quality of Life in Individuals With Hallux Valgus
Purpose: The purpose of this study is to evaluate the clinical, radiological, and biomechanical effects of Kinesio Taping (KT) when integrated into a standard exercise program for individuals with Hallux Valgus (HV). Hallux valgus is a progressive deformity of the first metatarsophalangeal (MTP) joint that leads to pain, functional impairment, and gait disturbances. While conservative treatments like exercises are common, the specific impact of KT on dynamic plantar pressure distribution and radiological angles requires further objective evidence.
Methods: A total of 50 participants (aged 18-65) with mild-to-moderate HV are randomized into two groups. Group 1 receives a 4-week intervention consisting of specialized Kinesio Taping applied once a week plus a daily home exercise program. Group 2 performs the same home exercise program only.
Assessments: Assessments include radiological measurements (Hallux Valgus Angle - HVA and Intermetatarsal Angle - IMA), clinical pain levels via the Visual Analog Scale (VAS), functional status via the American Orthopaedic Foot and Ankle Society (AOFAS-MTP-IP) scale, and dynamic pedobarographic analysis using the Zebris® FDM-2 system. Physical exercise capacity is also measured by the 6-Minute Walk Test (6MWT).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Kocasinan
-
Kayseri, Kocasinan, Turecko (Türkiye)
- Kayseri City Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Women and men between the ages of 18-65
- People with mild or moderate stage hallux valgus
- People with VAS 3 and above
Exclusion Criteria:
- Neuromuscular diseases that limit clinical exercise, uncontrolled psychiatric diseases or cognitive-cognitive disorders
- Patients who have received physiotherapy to the foot area in the last 6 months
- Presence of uncontrolled systemic diseases
- Malignancy
- Infection
- High fever
- Acute inflammatory rheumatic diseases
- Acute peripheral vascular diseases
- Patients with previous foot surgery
- Patients with skin lesions in the foot area
- Patients with rheumatoid arthritis
- Patients without cooperation and compliance
- Patients who did not agree to participate in the study
- Patients with foot osteoarthritis
- Patients with gouty arthritis
- Patients allergic to kinesio tape material
- Patients with hallux rigidus
- Other lower extremity alignment disorders (genu varum/valgum, developmental hip dysplasia etc.)
- People who have a history of using foot orthosis
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Kinesio Taping and Exercise
While applying kinesio tape, individuals will also be given home exercises.
|
Kinesio taping for correcting hallux valgus deformity
Patients will do exercise for correcting hallux valgus deformity
|
|
Aktivní komparátor: Exercise
Individuals will be given only home exercises
|
Patients will do exercise for correcting hallux valgus deformity
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Visual Analog Scale (VAS)
Časové okno: 4 weeks
|
A type of pain scale.
It has a value between 0 and 10.
A decrease in the value is associated with improvement.
|
4 weeks
|
|
Hallux Valgus and Intermetatarsophalengeal Angle
Časové okno: 4 weeks
|
4 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Six Minute Walk Test
Časové okno: 4 weeks
|
4 weeks
|
|
|
Plantar Pressure Measurements
Časové okno: 4 weeks
|
4 weeks
|
|
|
Plantar Force Measurements
Časové okno: 4 weeks
|
4 weeks
|
|
|
American Orthopaedic Foot and Ankle Society Metatarsophalangeal - Interphalangeal Scale (AOFAS-MTP-IP)
Časové okno: 4 weeks
|
It has a value between 0 and 100.
An increase in the value is associated with improvement.
|
4 weeks
|
|
Foot Rotation Degree
Časové okno: 4 weeks
|
4 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KayseriCH_MBurakOrten001
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