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Clinical Trials/NCT07521280
NCT07521280
Not yet recruiting
Not Applicable

Feasibility and Preliminary Clinical Evaluation of a State-Based Load Tolerance and Rule-Based Individualized Rehabilitation Pathway in Youth Athletes With Current or Previous Lower-Extremity Apophyseal Pain

Medical University of Gdansk1 site in 1 country45 target enrollmentStarted: April 5, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
45
Locations
1
Primary Endpoint
Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Sessions

Overview

Brief Summary

The goal of this clinical trial is to learn if a state-based rehabilitation program is feasible and helpful for children and adolescents with current or past 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 and whether the program can be delivered as planned. The main questions it aims to answer are:

  1. Can this rehabilitation program be delivered with good attendance, good home-exercise adherence, and complete follow-up data?
  2. Do pain, function, and sports participation improve during the rehabilitation period?

All participants will receive the rehabilitation pathway. The program is adjusted to each participant's clinical presentation, pain irritability, activity limits, and main physical deficits.

Participants will:

  • Attend baseline and follow-up physiotherapy assessments
  • Receive a rehabilitation plan that includes education, pain and load monitoring, and individualized exercises
  • Complete home exercises and keep a short symptom and activity log
  • Attend in-person physiotherapy sessions during the rehabilitation period
  • Answer questionnaires about pain, function, and sports participation during follow-up

Detailed Description

This study evaluates a structured 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 rehabilitation pathway combines a state-based early load-management framework with a rule-based individualized exercise program and education for safe return to sport.

The rehabilitation pathway is built around the Load Tolerance and Participation (LTP) Module. This module is used to classify each participant's current clinical state before rehabilitation progression. Classification is based on symptom irritability, participation restriction, clinical complexity, and recent load history. The purpose of this classification is to guide early decisions about activity modification, pain monitoring, exercise starting level, and progression or temporary regression of loading.

All participants in this study receive the same overall rehabilitation framework. However, the content is individualized using predefined decision rules rather than clinician preference alone. Each participant receives: (1) a mandatory core module focused on pain/load tolerance, education, and activity modification; (2) one main deficit-targeted exercise module, selected according to baseline clinical findings; and (3) an optional additional module only when a second deficit is clearly present and clinically relevant. Deficit-targeted modules may address range of motion/flexibility, strength, or motor control.

This study includes three pre-specified rehabilitation entry pathways. The first pathway includes participants who enter rehabilitation after completing the separate 2-week sham-controlled photobiomodulation trial (NCT07446517). The second pathway includes participants with active apophyseal pain who are not enrolled in that trial and enter rehabilitation directly after baseline assessment. The third pathway includes participants with a history of Osgood-Schlatter-related or Sever-related symptoms, or those with low-irritability/residual presentations, who enter rehabilitation directly in a lower-intensity or simplified pathway. These pathways are defined at study entry and will be used for pre-specified exploratory subgroup analyses. They are not intended to support causal comparisons of treatment effectiveness between groups.

The rehabilitation phase includes in-person physiotherapy visits and a home exercise program. During follow-up, participants and families are instructed in pain monitoring, symptom-guided activity modification, weekly tracking of symptoms and sport exposure, and safe stepwise return to sport. Rehabilitation progression is guided by predefined pain-monitoring rules and trend monitoring across time, rather than by fixed timelines alone.

This rehabilitation study is methodologically linked to the separately registered pilot sham-controlled photobiomodulation trial in youth athletes with apophyseal pain. Participants who complete that trial may enter this rehabilitation study through the post-trial pathway. However, the present study is focused on the rehabilitation pathway itself and is registered separately because the rehabilitation intervention, timing of entry, and clinical questions differ from those of the photobiomodulation trial.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

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.

Eligibility Criteria

Ages
10 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged 10 to 17 years
  • Participates in organized sport and has at least 12 months of sport participation or training history
  • Has current or previous lower-extremity apophyseal pain consistent with Osgood-Schlatter-related knee pain and/or Sever-related heel pain
  • Meets criteria for at least one pre-specified rehabilitation entry pathway:
  • post-RCT rehabilitation entry after completion of the separate photobiomodulation trial, or
  • direct-entry rehabilitation with active symptoms, or
  • direct-entry rehabilitation with a history of Osgood-Schlatter-related or Sever-related symptoms and a low-irritability/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 or sport participation

Exclusion Criteria

  • Current pain episode started after an acute traumatic injury that better explains 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 or interpretation
  • Known serious musculoskeletal, neurological, rheumatological, inflammatory, autoimmune, 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
  • 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

Arms & Interventions

State-Based Rehabilitation Pathway

Experimental

Participants in this arm receive a structured state-based 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, and a rule-based individualized exercise program. All participants receive the same overall rehabilitation framework, but the content and progression are adjusted using pre-defined clinical decision rules based on symptom irritability, participation restriction, recent load history, maturation context, and main physical deficits. Participants may enter this rehabilitation pathway through different pre-specified entry routes, including after completion of a separate photobiomodulation trial, by direct entry with active symptoms, or by direct entry with a history of Osgood-Schlatter-related or Sever-related symptoms and low-irritability/residual presentation.

Intervention: State-Based Rehabilitation Pathway (Behavioral)

Outcomes

Primary Outcomes

Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Sessions

Time Frame: 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

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, including LTP-based review, pain/load monitoring, exercise progression 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.

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bartosz Wilczyński

Principal Investigator

Medical University of Gdansk

Study Sites (1)

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