Effects of the Medial Longitudinal Slope on Clinical Parameters and Acceleration Impacts During Gait
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- Maximum tibial acceleration (g).
研究概览
简要总结
The objective of this clinical trial is to compare the effects of the geometry of the medial longitudinal arch (MLA) of the insole on acceleration impacts during gait, measured using an accelerometry system, in patients with pain related to the presence of a pronated foot morphotype. The main questions it aims to answer are:
Is the slope of the medial longitudinal arch of the orthotic treatment a factor that reduces the peak tibial accelerometry in a symptomatic foot with a medially oriented subtalar joint axis? To assess the predictive effect of changes in acceleration impacts on the patient's painful symptoms.
The researchers will compare the MLA of the insole taken in a standing position with the MLA of the insole taken in a sitting position (the treatment applied in routine clinical practice) to evaluate if changing the slope of the MLA generates changes in the tibial acceleration impacts.
The participants:
Must use the insoles to carry out their daily activities, except for sleeping or bathing.
The first review of the orthotic treatment will be conducted 3 months after the treatment initiation.
详细描述
Study Population The study population will consist of patients treated from June 2024 onwards at the Pathology and Orthopedics Service of the University Clinic of Podiatry at Complutense University of Madrid. All participants will be informed beforehand about the characteristics, objectives, and methodology of the present study and must consent by signing the informed consent form, which complies with the regulatory legislation under the Organic Law on Data Protection and guarantee of digital rights 3/2018, of December 5, and Law 41/2002, of November 14, which regulates the patient's autonomy and rights and obligations in terms of information and clinical documentation. (Organic Law 3/2018) recognizes a series of rights for citizens, such as the right of access, rectification, cancellation, and opposition to their personal data, the right to limit the treatment of incorrect data, request a copy, or transfer the data provided for the study to a third party (portability), to the extent that they are applicable.
Sample Size A sample size is estimated for the comparison of two independent proportions at a 5% significance level, an 80% statistical power, and a two-tailed test. Since no published study has evaluated exactly the angulation in both sitting and standing positions under the same conditions, reference values are not precisely known. However, it is estimated that the main outcome variable, peak acceleration, will behave similarly. There is a threshold for this variable at 8 g, such that a peak above this is a risk factor for developing lower limb pathology. In our study, it is expected that only 5% of patients in group A will have a peak above 8 g, while 30% of patients in group B will have a peak above 8 g. Considering these factors and anticipating a 15% possible dropout rate, a minimum sample size of 37 patients per group is needed to achieve the main objective, totaling 74 patients.
Analyzed Variables and Data Collection Procedures Patient data recording will begin on the first consultation day after conducting the relevant screening and fulfilling the established inclusion and exclusion criteria. All data will be collected in a data collection notebook, with each patient assigned an identification code to safeguard compliance with the Organic Law on Data Protection and guarantee of digital rights 3/2018, of December 5, and Law 41/2002, of November 14, which regulates the patient's autonomy and rights and obligations in terms of information and clinical documentation.
Dependent Variables
Outcome Variables:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes, aged over 18 years. Patients with painful symptoms in the lower limb associated with a Foot Posture Index (FPI-6) score > 5, indicative of foot pronation position.
- •Navicular Drop Test > 10 mm. Subjects with painful symptoms associated with foot pronation position. Signed informed consent explaining the study's characteristics and objectives.
排除标准
- •Subjects presenting at least one of the following conditions will be excluded:
- •Previous diagnosis of neurological or rheumatological systemic disease. History of foot or ankle surgery resulting in limitations in the mobility of the subtalar, midtarsal, or metatarsophalangeal joints.
- •History of leg, ankle, or foot fracture resulting in limitations in the mobility of these structures.
- •Lower limb morpho-functional alteration: clinical asymmetry greater than 5 mm, presence of genu varum, genu valgum with a difference of more than 2° femoro-tibial between limbs, internal or external femoral torsion.
- •Cognitive impairment preventing understanding of the study's objectives and compliance with participation guidelines.
- •Patients unable to walk independently due to musculoskeletal injury in the lower limbs within the last 6 months.
- •Currently receiving any analgesic treatment for the lower limbs at the time of intervention.
结局指标
主要结局
Maximum tibial acceleration (g).
时间窗: The maximum tibial acceleration (g) is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.
Tibial axial acceleration corresponds to a line bisecting the proximal and distal ends of the tibia in the frontal and sagittal planes. Longitudinal acceleration provides a measure of impact accelerations at the knee moving longitudinally along the tibia and has previously been identified as a potential indicator of injury risk.
次要结局
- Magnitude of head acceleration (g).(The magnitude of head acceleration (g) is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.)
- Maximum head acceleration (g)(The maximum head acceleration (g) is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.)
- Acceleration ratio (38-70) in head (g/s).(Acceleration ratio (38-70) in head (g/s). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system)
- Magnitude of tibial acceleration (g)(Magnitude of tibial acceleration (g). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.)
- Impact attenuation (%)(Impact attenuation (%). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.)
- Acceleration ratio (30-70) in tibia (g/s).(Acceleration ratio (30-70) in tibia (g/s). It is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.)