Feasibility, Clinical Response, and Exploratory Predictors of an Individualized Load-Based Rehabilitation Pathway in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Prospective Single-Arm Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Sessions
研究概览
简要总结
The goal of this clinical trial is to learn if a 12-week individualized rehabilitation program is feasible and helpful for children and adolescents with lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. It will also learn about how well participants follow the program, whether the program can be delivered as planned, and whether pain, function, and sports participation improve during rehabilitation.
The main questions it aims to answer are:
- Can this rehabilitation program be delivered with good attendance, good home-exercise adherence, and complete follow-up data?
- Do pain, function, and sports participation improve during the rehabilitation period?
- Which baseline clinical, functional, ultrasound, maturity, or biomarker features may help explain who responds better to rehabilitation?
All participants will receive the same overall rehabilitation framework. The program includes education, pain and load monitoring, an activity-ladder approach, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to running, jumping, landing, and sport-specific activities. Exercises are individualized according to symptoms, current activity level, movement quality, treatment tolerance, and clinical judgement.
Participants will:
- Attend baseline and follow-up physiotherapy assessments.
- Receive an individualized rehabilitation plan with education, pain and load monitoring, and home exercises.
- Complete home exercises and keep a short symptom and activity log.
- Attend in-person physiotherapy review visits during the rehabilitation period.
- Answer questionnaires about pain, function, perceived change, and sports participation during follow-up.
详细描述
This study evaluates a 12-week individualized rehabilitation pathway for youth athletes with current or previous lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. The study is designed as a prospective, single-arm interventional feasibility study with exploratory clinical-response and predictor analyses.
The rehabilitation pathway includes a standardized core framework delivered to all participants. The core components are education, pain and load monitoring, activity modification, symptom-guided progression, home-exercise prescription, basic strength exposure, motor-control training, and gradual return to sport-related loading. The main clinical emphasis is on improving load tolerance and movement quality during tasks relevant to youth sport, such as squatting, single-leg control, step or split-squat patterns, calf-loading tasks, landing, deceleration, running, and sport-specific activities.
The intervention is individualized pragmatically rather than by formal treatment allocation rules. Exercise dose, starting level, range of motion, external load, volume, progression, and temporary regression are individualized according to symptoms, current participation level, irritability, movement quality, exercise tolerance, and symptom response during and after loading. Exercise selection may also be modified when clinically indicated. Baseline clinical and functional tests may include measures of range of motion, muscle strength, movement quality, ultrasound features, maturation, and biomarkers. These measures are used for participant characterization, safety monitoring, and exploratory predictor or moderator analyses. They are not used as a deterministic algorithm for assigning participants to separate treatment modules.
All participants receive the same overall rehabilitation pathway, but the exact exercise variants, starting level, loading dose, rate of progression, and temporary regressions may differ between participants. The rehabilitation program includes in-person physiotherapy visits at baseline and planned review time points, together with a home exercise program. Participants and families receive instructions on how to monitor pain, symptoms, and sport exposure, and how to respond if symptoms increase.
Progression is guided by symptom response and movement quality rather than by fixed timelines alone. Pain during exercise, symptom response after the session and the next day, perceived exertion, and visible movement quality are used to decide whether to maintain, progress, regress, or temporarily pause selected exercises or activity levels. Participants are instructed to report relevant symptom worsening, limping, swelling, new pain, or adverse events to the physiotherapy team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label rehabilitation study. Participants, families, and treating physiotherapists are aware that rehabilitation is being delivered. Because the intervention includes education, exercise instruction, and activity modification, masking of participants and care providers is not feasible.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10 to 17 years
- •Participates in organized sport and has at least 12 months of sport participation or training history
- •Has current lower-extremity apophyseal pain consistent with Osgood-Schlatter-related knee pain and/or Sever-related heel pain, or has previous Osgood-Schlatter-related or Sever-related symptoms with a residual or low-irritability presentation relevant to rehabilitation
- •Meets criteria for at least one pre-specified rehabilitation entry pathway:
- •post-trial rehabilitation entry after completion of the separate photobiomodulation trial, or direct-entry rehabilitation with active apophyseal symptoms, or direct-entry rehabilitation with previous Osgood-Schlatter-related or Sever-related symptoms and a low-irritability or residual presentation
- •For participants entering with active symptoms:
- •pain is located at the tibial tubercle region and/or the calcaneal apophyseal/heel region
- •pain is aggravated by activity, loading, or sport participation
- •pain is reproducible on clinical examination or the clinical history is consistent with the target condition
- •Participant and parent/caregiver are willing to take part in the rehabilitation program, including in-person visits, home exercises, symptom/activity monitoring, and follow-up assessments.
- •A parent or legal guardian provides written informed consent, and the participant provides assent when applicable.
排除标准
- •Current pain episode started after an acute traumatic injury that better explains the symptoms
- •Clinical presentation suggests a condition other than the target rehabilitation condition, including a major alternative knee or heel diagnosis requiring different management
- •Lower-limb surgery that would substantially affect rehabilitation planning, safety, or interpretation of outcomes
- •Known serious musculoskeletal, neurological, rheumatological, inflammatory, autoimmune, metabolic, or other systemic disease that may affect safe participation or interpretation of outcomes
- •Any medical or developmental condition that would prevent safe participation in exercise-based rehabilitation
- •Current symptoms requiring urgent medical assessment or management outside the rehabilitation pathway
- •Inability to understand study instructions or complete study procedures with parent/caregiver support
- •Parent/caregiver or participant does not agree to participate or withdraws consent/assent
研究组 & 干预措施
Individualized Load-Based Rehabilitation Pathway
Participants receive a 12-week individualized rehabilitation pathway for current or previous lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. The intervention includes education, pain and load monitoring, activity modification, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to sport-related loading. All participants receive the same overall rehabilitation framework, but the starting level, exercise variants, dose, progression, and temporary regressions are adjusted according to symptoms, current activity level, movement quality, treatment tolerance, response after exercise, and clinical judgement. Participants may enter after completion of a separate photobiomodulation trial, by direct entry with active symptoms, or by direct entry with previous symptoms and a low-irritability or residual presentation. These entry routes are not treatment arms.
干预措施: Individualized Load-Based Rehabilitation Pathway (Behavioral)
结局指标
主要结局
Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Sessions
时间窗: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Proportion of participants who complete the planned in-person physiotherapy sessions within the rehabilitation period. Completion will be defined according to the individualized rehabilitation schedule, with successful completion operationalized as attendance at the minimum planned core session set.
Home Exercise Adherence During the Rehabilitation Period
时间窗: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Proportion of participants achieving the pre-specified home-exercise adherence target, defined as completing home exercises during at least 70% of study weeks.
Retention: Proportion of Participants Completing Follow-Up Assessment
时间窗: From rehabilitation entry to end-of-study follow-up (approximately 12 weeks)
Proportion of enrolled participants who complete the planned follow-up assessment at the end of the rehabilitation period.
Safety: Number and Type of Adverse Events During Rehabilitation
时间窗: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Count and classification of adverse events temporally associated with the rehabilitation program, including symptom flare requiring modification, new musculoskeletal injury, or other clinically relevant problems during study participation.
Intervention Fidelity: Proportion of Rehabilitation Visits Delivered According to Protocol
时间窗: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Proportion of in-person rehabilitation visits in which the required protocol elements were delivered and documented. Required elements include pain and load monitoring, review of symptoms and activity exposure, exercise review, progression or regression decision, and home-program update.
Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Review Visits
时间窗: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Proportion of participants who complete the planned in-person physiotherapy review visits during the 12-week rehabilitation period. Successful completion will be defined as attendance at the minimum planned core visit set, including baseline rehabilitation entry and at least the planned follow-up review visits required by the protocol.
次要结局
- Change From Baseline in Worst Pain During the Last 7 Days as Measured by the Numeric Pain Rating Scale (NPRS)(Baseline and approximately 12 weeks)
- Change From Baseline in Knee Function as Measured by the Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child) in the Osgood-Schlatter Subgroup(Baseline and approximately 12 weeks)
- Change From Baseline in Foot/Ankle Function as Measured by the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) in the Sever Subgroup(Baseline and approximately 12 weeks)
- Return-to-Sport Status at Follow-Up(Approximately 12 weeks)
- Proportion of Participants Reporting Meaningful Improvement on the Patient Global Impression of Change (PGIC) at Approximately 12 Weeks(Approximately 12 weeks)
- Proportion of Participants Re-entering the Load Tolerance and Participation (LTP) Module During Rehabilitation(From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks))
- Proportion of Participants Requiring Rehabilitation Regression or Temporary Exercise Modification During the Rehabilitation Period(From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks))
研究者
Bartosz Wilczyński
Principal Investigator
Medical University of Gdansk