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Exercise Therapy and Physical Activity Modification for Patients With Sever's Disease (SDX)

2026年11月5日 更新者：Shawn Hanlon、California State University, Fullerton

Exercise Therapy and Physical Activity Modification for Patients With Sever's Disease: A Randomized Controlled Trial

Sever's disease is an overuse injury to the calcaneal growth plate caused by repetitive traction stress from the Achilles tendon in youth. Limited evidence exists to guide effective treatment for Sever's disease and disrupt short- and long-term pain and disability. Exercise therapy has the strongest evidence to promote tissue healing and is supported for other growth plate injuries. This study aims to determine if a comprehensive exercise therapy and activity modification intervention produces a clinically meaningful improvement in (Aim 1) pain and lower extremity function, (Aim 2) muscle and tendon structure, and (Aim 3) physical activity, compared to a non-exercise palliative approach for patients with Sever's disease. Differences between groups after completing 12 weeks of intervention.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
招聘中

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

Sever's disease (calcaneal apophysitis) is a debilitating overuse injury to the calcaneal apophysis (growth plate) caused by repetitive traction stress on the growth plate. The condition occurs in 3.7 per 1,000 young patients, most commonly between ages 8-15 years old. Patients with Sever's disease experience months of heel pain with running and jumping activities, reduced quality of life, and struggle to participate in social and sports activities. Symptoms can progress from self-limiting to complete loss of function and may persist into adulthood, leading to early retirement from sport. Therefore, effective rehabilitation is essential to curb the substantial negative implications on physiological and psychological health that may continue into adulthood and contribute to healthcare utilization and global physical inactivity trends.

There is a lack of high-quality evidence to guide intervention for Sever's disease. Expert opinion maintains that pain and dysfunction resolve spontaneously when patients reach skeletal maturity. As a result, palliative interventions consisting of activity avoidance or cessation are often prescribed for symptom relief. At the tissue level, these passive strategies risk the healthy maturation of load-bearing tissues through physical activity (PA) in the most critical years of growth.Recent evidence of altered Achilles tendon structure in patients with Sever's disease suggests this condition may have lifelong implications. This underscores an immediate need to develop an evidence-based treatment strategy that supports tissue remodeling during this critical time of growth and encourages a physically active lifestyle in adulthood. Exercise therapy promotes tissue healing and is effective for patients with Achilles tendinopathy and other apophyseal injuries. Our pilot study determined that this treatment approach is feasible and safe for patients with Sever's disease and preliminary results support conducting a larger clinical trial to determine efficacy to improve clinical outcomes. We propose to conduct a 12-week randomized controlled trial to evaluate the effectiveness of a comprehensive tendon-loading protocol compared to a palliative control approach for treating Sever's disease. The experimental group (EXP) will receive a comprehensive intervention including a tendon-loading protocol and education on daily pain monitoring to allow continued sports participation within a tolerable pain range. The control group (CTL) will be instructed to participate in activities of daily life and sports as tolerated. Both groups will be provided gel heel cups and an activity diary. Both groups will be asked to don a wearable ActivPAL activity monitor for seven consecutive days after data collection at baseline, 6-, and 12- weeks. Our specific aims are: (1) To determine if the comprehensive intervention produces clinically meaningful improvement in symptom severity, lower extremity function, and psychosocial factors compared to palliative care over 12 weeks. (2) Evaluate changes in triceps surae and Achilles tendon morphology and mechanical properties over time. (3) Explore weekly PA volume and intensity at time of diagnosis and changes during intervention.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
60

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。

学习地点

  • 美国
    • California
      • Fullerton、California、美国、92831
        • 招聘中
        • Kinesiology and Health Sciences Building
        • 接触：
        • 接触：
        • 首席研究员：
          • Shawn L Hanlon, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

8年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Insidious onset of heel pain over several weeks
  • Pain on palpation of the calcaneus or Achilles tendon
  • Complaint of heel pain with running or jumping activities.

Exclusion Criteria:

  • Any underlying condition predisposing heel pain (i.e., spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
  • Any other injury that limits their ability to run or jump.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：Experimental Group

The experimental group will receive supervised progressive tendon-loading exercise therapy, pain-guided activity modification education, and feedback on daily activity. Both groups will receive gel heel cushion inserts for footwear.
行为的：Exercise

Therapeutic Achilles-tendon loading exercise; Activity modification using a Pain Monitoring Model
有源比较器：Control Group

The control group will not receive progressive tendon-loading exercise. The control group will receive the same education as the experimental group, except the control group will be asked to participate in activities as tolerated and rest as needed. The control group will be asked to record the same activity diary as the experimental group, but will not receive feedback on their daily activity. Both groups will receive gel heel cushion inserts for footwear.
其他：Active Control

Conventional Clinician advice for pediatric overuse injury management.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Self-reported Achilles tendon or heel pain and Symptoms with Activity
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

The Victorian Institute of Sport Assessment-Achilles (VISA-A) will be used. Survey completed via participant interview at baseline. Survey completed online by participants for follow-up visits.
Baseline, 6 weeks, and 12 weeks after randomization.

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Single-leg Countermovement Jump Height
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

Participants will be instructed to keep their arms behind their back and jump as high as possible on a flat surface. Jump height will be measured in cm via the MuscleLab contact grid.
Baseline, 6 weeks, and 12 weeks after randomization.
Single-leg Drop Countermovement Jump Height
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

The drop CMJ is performed by standing on the edge of a 20cm box, then stepping off to land and immediately rebounding as high as possible. Jump height will be measured in cm via the MuscleLab contact grid.
Baseline, 6 weeks, and 12 weeks after randomization.
Total Heel-rise Work
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

The heel-rise endurance test is performed barefoot while standing on a single leg on a slant board fixed at 10 degrees of dorsiflexion. Participants will be instructed to perform as many heel-rises as possible while maintaining a straight knee and a slight forward lean, lifting the heel as high as possible, to a metronome set at 60 beats/min (30 heel-rises/min). Participants will place only two fingers from each hand on the wall to maintain balance. The test will conclude when the participant is unable maintain the test cadence, elect to stop due to fatigue or pain, or perform consistent repetitions with compensation. A linear encoder will be taped to the posterior calcaneus, which records linear displacement (heel-rise height, cm) for each repetition. Total heel-rise work will be calculated in Joules by summing the displacement for each repetition, multiplied by body mass and the force of gravity.
Baseline, 6 weeks, and 12 weeks after randomization.
Achilles Tendon Cross-sectional Area
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

B-mode ultrasound imaging (GE P9 Xdclear R4.5, GE Healthcare) will be used to assess the Achilles tendon cross-sectional area in short-axis images. CSA will be measured at the thickest portion of the free Achilles tendon.
Baseline, 6 weeks, and 12 weeks after randomization.
Shear Wave Velocity
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

Shear wave velocity (SWV) will be measured using Ultrasound Shear Wave Elastography. SWV is a measurement of resistance to deformation (stiffness) in tendon. Participants will be positioned prone, with legs past the mid-shank suspended over the edge of the exam table and feet resting against a custom wall-mounted slant board to fix the ankles at 15 degrees of dorsiflexion. The region of interest will be between the anterior-posterior borders of the Achilles tendon visualized on b-mode ultrasound imaging in longitudinal axis and centered over the thickest portion of the free Achilles tendon. This distance will be documented from the cephalad border of the Achilles tendon osteotendinous junction (calcaneal notch). In cases of uniform thickness, the ROI will be standardized to 2cm proximal to the calcaneal notch. The average of three trials will be analyzed.
Baseline, 6 weeks, and 12 weeks after randomization.
Achilles Tendon Echogenicity
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

The percentage of white to greyscale pixels (range 0-255) is calculated within a region of interest using the LAX Achilles tendon thickness images.
Baseline, 6 weeks, and 12 weeks after randomization.
Daily Step Count
大体时间：2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.

Number of steps taken during waking hours measured using a wearable accelerometer- and inclinometer-based sensor (ActivPAL). Participants will wear the device continuously for 7 days at each study time point.
2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.
Daily Activity Minutes
大体时间：2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.

Daily minutes/day spent sitting, standing, stepping, and being sedentary will be averaged for each participant across all valid days using a wearable accelerometer- and inclinometer-based sensor (ActivPAL4+). Participants will wear the device continuously for 7 days at each study time point. Additionally, daily minutes at a moderate-to-vigorous activity stepping cadence will be analyzed.
2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.
Foot and Ankle Outcome Score
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.

Assesses foot and ankle-related symptoms, function, participation, and quality of life
Baseline, 6 weeks, and 12 weeks after randomization.
Tampa Scale For Kinesiophobia
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.
Baseline, 6 weeks, and 12 weeks after randomization.
Oxford Foot And Ankle Questionnaire Child Version
大体时间：Baseline, 6 weeks, and 12 weeks after randomization.
Baseline, 6 weeks, and 12 weeks after randomization.
Global Rating of Change
大体时间：6 weeks, and 12 weeks after randomization.

"Please rate the overall change in your condition from the time that you began the study until now." Measured on an 11-point likert scale, where -5 is "A very great deal worse", 0 is "No change", and +5 is "A very great deal better".
6 weeks, and 12 weeks after randomization.
Global Rating of Function
大体时间：6 weeks, and 12 weeks after randomization.

"On a scale of 0 - 100, please rate the use/function of your injured body part?" 0 is No Function/Unable to Use Injured Body Part, and 100 is ull Function/ Full use of Injured Body Part.
6 weeks, and 12 weeks after randomization.
Satisfaction
大体时间：6 weeks, and 12 weeks after randomization.

"How satisfied are you with the current use/function of your injured body part?" 0-10 scale, where 0 is "Not satisfied" and 10 is "Very satisfied".
6 weeks, and 12 weeks after randomization.
Patient Acceptable Symptom Scale
大体时间：6 weeks, and 12 weeks after randomization.

"Considering all the activities and sports you do each day, how much you hurt, and what you can do with and without pain, are you satisfied with your current condition?" Yes/No answer.
6 weeks, and 12 weeks after randomization.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
California State University, Fullerton

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：Shawn L Hanlon, PhD、California State University, Fullerton

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2025年10月30日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2028年7月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2028年7月1日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年11月5日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月5日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年11月10日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年11月10日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月5日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • HSR-25-26-54
  • #25NIP02 (其他赠款/资助编号：National Athletic Trainers' Association Research and Education Foundation)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data will be shared upon reasonable request as decided by the Principal Investigator.

IPD 共享时间框架

At the conclusion of data collection (est. July 31, 2028).

IPD 共享访问标准

Data will be made publicly available no later than six months after the final publication.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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