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
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
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:
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:
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.
The rehabilitation pathway uses an activity-ladder approach to guide return to participation. Sport participation and load exposure are monitored separately, because a participant may tolerate some parts of training while still being unable to tolerate higher-load tasks such as sprinting, jumping, landing, rapid deceleration, or match play. Return to sport is therefore progressed stepwise and individualized to symptom response.
The study also includes exploratory responder and predictor analyses. Baseline clinical features, symptom irritability, functional performance, ultrasound findings, maturity-related variables, and selected biomarkers may be examined as potential predictors or moderators of clinical response. These analyses are exploratory and are not intended to establish causal treatment effects between subgroups.
This rehabilitation study is methodologically linked to the separately registered pilot sham-controlled photobiomodulation trial in youth athletes with apophyseal pain (NCT07446517). Participants who complete that trial may enter this rehabilitation study through a post-trial pathway. Other eligible participants may enter the rehabilitation study directly after baseline assessment. The present study is registered separately because the rehabilitation intervention, timing of entry, and clinical questions differ from those of the photobiomodulation trial.
Inclusion Criteria:
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:
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.
Exclusion Criteria:
bartosz.wilczynski@gumed.edu.pl+48 732 414 195