Osgood-Schlatter DiseaseLEAP-REHABNCT07521280
Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
A study testing Individualized Load-Based Rehabilitation Pathway in people with Osgood-Schlatter Disease and Sever's Disease, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Osgood-Schlatter Disease, Sever's Disease, Apophyseal Pain
- What is being tested?
- Individualized Load-Based Rehabilitation Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- 20 Apr 2026to 5 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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, Sever-related heel pain, and/or Sinding-Larsen-Johansson-related pain at the inferior pole of the patella, or has previous symptoms of these conditions 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:
Show all 11Show fewer
- pain is located at the tibial tubercle region, the inferior pole of the patella, 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Immunobiology and Environment Microbiology
Gdansk, Debinki 7, 80-210
Bartosz Wilczyński, 58 349 17 66 ext. +48, immunobiol@gumed.edu.pl
Bartosz Wilczyński
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
Participants with Sinding-Larsen-Johansson syndrome follow the knee pathway and are analyzed as a separate descriptive subgroup. The primary analysis includes participants with Osgood-Schlatter or Sever disease, and a sensitivity analysis includes the Sinding-Larsen-Johansson subgroup.
Participants record weekly home-exercise sessions and symptom response in an electronic diary (REDCap or MyCap) hosted by the Medical University of Gdansk, and adherence is calculated from these records. The exercise portal provides exercise videos and instructions only and is not a data source for the registered outcomes.
- Conditions
- Osgood-Schlatter Disease, Sever's Disease, Apophyseal Pain, Sinding-Larson and Johansson Syndrome (SLJ)
- Being tested
- Individualized Load-Based Rehabilitation Pathway
- Keywords
- Osgood-Schlatter Disease, Sever's Disease, Knee Pain, Heel Pain, Return to Sport, Load Management, Apophyseal Pain, Youth Athletes, Exercise Therapy, Physical Therapy, Rehabilitation
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Load-Based Rehabilitation PathwayBehavioural
Also called Activity-Ladder Rehabilitation, Symptom-Guided Rehabilitation Program, Load-Tolerance Rehabilitation Program
This intervention is a 12-week individualized rehabilitation program for youth athletes with current or previous lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. The program 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. 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. Progression is guided by pain during exercise, symptom response after the session and the next day, perceived exertion, and movement quality, rather than by fixed timelines alone.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Load-Based Rehabilitation Pathway | Experimental | 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. Receives: Behavioral: Individualized Load-Based Rehabilitation Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Review Visits
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.
Measured: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Home Exercise Adherence During the Rehabilitation Period
Proportion of participants achieving the pre-specified home-exercise adherence target, defined as completing home exercises during at least 70% of study weeks.
Measured: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Intervention Fidelity: Proportion of Rehabilitation Visits Delivered According to Protocol
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.
Measured: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Retention: Proportion of Participants Completing Follow-Up Assessment
Proportion of enrolled participants who complete the planned follow-up assessment at the end of the rehabilitation period.
Measured: From rehabilitation entry to end-of-study follow-up (approximately 12 weeks)
Safety: Number and Type of Adverse Events During Rehabilitation
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.
Measured: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Secondary outcomes (6)
Change From Baseline in Worst Pain During the Last 7 Days as Measured by the Numeric Pain Rating Scale (NPRS)
NPRS ranges from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. The main metric will be change in worst pain in the last 7 days from baseline to follow-up.
Measured: 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
The Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child) is a child-reported knee-specific questionnaire. Subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better knee status, fewer symptoms, and better function. The primary metric will be change from baseline to approximately 12 weeks in the overall KOOS-Child score in the Osgood-Schlatter subgroup.
Measured: 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
The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child-reported measure of foot and ankle function. Domain scores are transformed to a 0 to 100 scale, where higher scores indicate better foot and ankle function and lower symptom impact. The metric is change from baseline to approximately 12 weeks in the overall OxAFQ-C score in the Sever subgroup only.
Measured: Baseline and approximately 12 weeks
Return-to-Sport Status at Follow-Up
Return-to-sport status will be classified using pre-specified participation categories describing the participant's current level of sport involvement, ranging from restricted participation to full return to sport without planned limitations. Status will be recorded as an ordinal category at follow-up to describe sport participation during and after rehabilitation.
Measured: Approximately 12 weeks
Proportion of Participants Reporting Meaningful Improvement on the Patient Global Impression of Change (PGIC) at Approximately 12 Weeks
PGIC is a 7-point scale of overall perceived change, ranging from very much improved to very much worse. Meaningful improvement is defined a priori as a rating of "much improved" or "very much improved." This outcome will be reported as the proportion of participants meeting that threshold at approximately 12 weeks.
Measured: Approximately 12 weeks
Proportion of Participants Requiring Rehabilitation Regression or Temporary Exercise Modification During the Rehabilitation Period
This outcome will be reported as the proportion of participants who require at least one clinically indicated regression or temporary modification of the rehabilitation program during the 12-week period. Regression or modification may include reducing exercise dose, reducing range of motion, reducing external load, simplifying the exercise variant, temporarily pausing a selected exercise, or modifying sport-related activity because of symptom worsening, reduced movement quality, adverse next-day response, or other clinical concerns.
Measured: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion5 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osgood-Schlatter DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group interventional rehabilitation study. All participants receive the same overall 12-week individualized rehabilitation pathway, including education, pain and load monitoring, activity modification, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to sport-related loading. The starting level, dose, progression, and temporary regression are adjusted according to symptoms, current activity level, movement quality, treatment tolerance, response after exercise, and clinical judgement. Participants may enter after the separate photobiomodulation trial, by direct entry with active apophyseal symptoms, or by direct entry with previous symptoms and a low-irritability/residual presentation. These entry routes are not treatment arms and will be used only for descriptive and exploratory subgroup analyses.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Wilczyński, Medical University of Gdansk
- Investigators
- Bartosz Wilczyński, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521280
- Sponsor's protocol ID
- KB/591/2025-2026-REHAB
- Other IDs
- 71-01428
- Acronym
- LEAP-REHAB
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in publications from this study will be made available to qualified researchers. Shared data may include baseline characteristics, rehabilitation entry pathway, intervention exposure variables, adherence and fidelity measures, clinical outcomes, and adverse events, together with a data dictionary. Data will be shared after publication of the primary results and will remain available for at least 5 years.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07521280
- Acronym / sponsor ID
- LEAP-REHAB / KB/591/2025-2026-REHAB
- Conditions
- Osgood-Schlatter Disease, Sever's Disease, Apophyseal Pain, Sinding-Larson and Johansson Syndrome (SLJ)
- Keywords
- Osgood-Schlatter Disease, Sever's Disease, Knee Pain, Heel Pain, Return to Sport, Load Management, Apophyseal Pain, Youth Athletes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 5 Apr 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Participants with Sinding-Larsen-Johansson syndrome follow the knee pathway and are analyzed as a separate descriptive subgroup. The primary analysis includes participants with Osgood-Schlatter or Sever disease, and a sensitivity analysis includes the Sinding-Larsen-Johansson subgroup.
Participants record weekly home-exercise sessions and symptom response in an electronic diary (REDCap or MyCap) hosted by the Medical University of Gdansk, and adherence is calculated from these records. The exercise portal provides exercise videos and instructions only and is not a data source for the registered outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group interventional rehabilitation study. All participants receive the same overall 12-week individualized rehabilitation pathway, including education, pain and load monitoring, activity modification, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to sport-related loading. The starting level, dose, progression, and temporary regression are adjusted according to symptoms, current activity level, movement quality, treatment tolerance, response after exercise, and clinical judgement. Participants may enter after the separate photobiomodulation trial, by direct entry with active apophyseal symptoms, or by direct entry with previous symptoms and a low-irritability/residual presentation. These entry routes are not treatment arms and will be used only for descriptive and exploratory subgroup analyses.
| Arm | Type | Receives |
|---|---|---|
| Individualized Load-Based Rehabilitation Pathway | Experimental | Behavioral: Individualized Load-Based Rehabilitation PathwayParticipants 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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, Sever-related heel pain, and/or Sinding-Larsen-Johansson-related pain at the inferior pole of the patella, or has previous symptoms of these conditions 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Load-Based Rehabilitation PathwayAlso: Activity-Ladder Rehabilitation, Symptom-Guided Rehabilitation Program, Load-Tolerance Rehabilitation ProgramThis intervention is a 12-week individualized rehabilitation program for youth athletes with current or previous lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. The program 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. 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. Progression is guided by pain during exercise, symptom response after the session and the next day, perceived exertion, and movement quality, rather than by fixed timelines alone. | Behavioural | Individualized Load-Based Rehabilitation Pathway |
Primary outcome
Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Review Visits
Time frame: 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.
Home Exercise Adherence During the Rehabilitation Period
Time frame: 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.
Intervention Fidelity: Proportion of Rehabilitation Visits Delivered According to Protocol
Time frame: 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.
Retention: Proportion of Participants Completing Follow-Up Assessment
Time frame: 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
Time frame: 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.
6 secondary outcomes
Change From Baseline in Worst Pain During the Last 7 Days as Measured by the Numeric Pain Rating Scale (NPRS)
Time frame: 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
Time frame: 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
Time frame: Baseline and approximately 12 weeks
Return-to-Sport Status at Follow-Up
Time frame: Approximately 12 weeks
Proportion of Participants Reporting Meaningful Improvement on the Patient Global Impression of Change (PGIC) at Approximately 12 Weeks
Time frame: Approximately 12 weeks
Proportion of Participants Requiring Rehabilitation Regression or Temporary Exercise Modification During the Rehabilitation Period
Time frame: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in publications from this study will be made available to qualified researchers. Shared data may include baseline characteristics, rehabilitation entry pathway, intervention exposure variables, adherence and fidelity measures, clinical outcomes, and adverse events, together with a data dictionary. Data will be shared after publication of the primary results and will remain available for at least 5 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bartosz Wilczyński principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Load-Based Rehabilitation Pathway in people with Osgood-Schlatter Disease and Sever's Disease, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Wilczyński, PhD (+48 732 414 195, bartosz.wilczynski@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Review Visits (time frame: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.