Acute Effects of Orthosis Use on Muscle Mechanical Properties in Individuals With Pes Planus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Change in Muscle Dynamic Stiffness
研究概览
简要总结
This randomized controlled study will examine the acute effects of a medial arch support and a prefabricated insole on lower-limb muscle mechanical properties and pain in young adults with pes planus. Ninety participants will be allocated in a 1:1:1 ratio to a medial arch support group, an insole group, or a control group. Muscle mechanical and viscoelastic properties will be assessed with MyotonPRO, and pain will be assessed with a visual analog scale.
详细描述
Participants will first undergo baseline assessments, followed by 30 minutes of treadmill walking at a self-selected speed and 0° incline while wearing comfortable shoes without an added orthosis. Dynamic stiffness, oscillation frequency, other MyotonPRO parameters, and pain will then be reassessed (T0). Participants in the medial arch support and insole groups will rest for 30 minutes and complete a second 30-minute walk at the same speed and incline with the assigned device placed inside the shoe. Outcomes will be reassessed immediately after this walk (T1). Participants in the control group will complete the study after the first, unassisted walking condition and T0 assessment; no T1 measurement is planned for this group. MyotonPRO assessments will include the tibialis anterior, peroneus longus, and medial and lateral gastrocnemius-soleus muscle groups, following the measurement procedures specified in the ethics application.
The control group will characterize the acute response to the initial unassisted walking task. Because the approved protocol does not include a second walking condition for the control group, analyses requiring T1 will be limited to the two orthosis groups. Between-group comparisons involving all three groups will use the time points available across all groups, including baseline and T0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to group allocation. The statistician will analyze the data using coded group labels.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-30 years
- •Diagnosed with unilateral or bilateral pes planus
- •Willing to participate voluntarily in the study
排除标准
- •History of lower-extremity injury or surgery within the past 6 months
- •Diagnosis of a rheumatologic or neurological condition that may affect foot joint alignment
- •Skin lesions or damage that may prevent the measurements from being performed
- •Current use of an orthosis, such as an insole or wedge, to support pes planus
- •Body mass index (BMI) ≥25 kg/m² or ≤18.5 kg/m²
- •Unwilling to participate in the study
研究组 & 干预措施
Medial Arch Support Group
Participants will walk on a treadmill for 30 minutes at a self-selected speed without arch support. After the post-walk assessment and a 30-minute rest period, they will repeat the same walking protocol with a medial arch support placed inside their shoes. Muscle mechanical properties and pain will be assessed before and after the walking sessions.
干预措施: Medial Arch Support (Device)
Insole Group
Participants will walk on a treadmill for 30 minutes at a self-selected speed without an insole. After the post-walk assessment and a 30-minute rest period, they will repeat the same walking protocol with an insole placed inside their shoes. Muscle mechanical properties and pain will be assessed before and after the walking sessions.
干预措施: Insole (Device)
Control Group
Participants will walk on a treadmill for 30 minutes at a self-selected speed without an arch support or insole. Muscle mechanical properties and pain will be assessed before and after the walking session. No additional walking session with an orthotic intervention will be performed.
结局指标
主要结局
Change in Muscle Dynamic Stiffness
时间窗: Baseline, immediately after the first 30-minute treadmill walking session (T0), and immediately after the second 30-minute walking session following a 30-minute rest period (T1)
Muscle dynamic stiffness will be measured using the MyotonPRO device and reported in newtons per meter (N/m). Higher values indicate greater muscle stiffness.
Change in Muscle Oscillation Frequency
时间窗: Baseline, immediately after the first 30-minute treadmill walking session (T0), and immediately after the second 30-minute walking session following a 30-minute rest period (T1). T1 measurements will only be performed in the medial arch support and insol
Muscle oscillation frequency will be measured using the MyotonPRO device and reported in hertz (Hz). Higher values indicate greater muscle tone.
次要结局
- Change in Pain Intensity(Baseline, immediately after the first 30-minute treadmill walking session (T0), and immediately after the second 30-minute walking session following a 30-minute rest period (T1). T1 measurements will only be performed in the medial arch support and insol)
研究者
Onur Köksal
Assistant Professor
Medipol University