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Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes

Study acronym: LEAP-REHAB
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Apr 5, 2027 → Jun 30, 2027
See other at-risk trials from Medical University of Gdansk

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Apr 5, 2027 to Jun 30, 2027 Show 4 more changesShow less
    • Start date: May 20, 2026 to Apr 20, 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description expanded, about 82 words
  2. Notable Recruitment opened
    • Study description expanded, about 15 words
    • Site details revised
    v3
  3. Notable Primary endpoint(s) modifiedv2 Show 6 more changesShow less
    • Start date: Apr 5, 2026 to May 20, 2026
    • Interventions: State-Based Rehabilitation Pathway (Behavioral) to Individualized Load-Based Rehabilitation Pathway (Behavioral)
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 100 words
    • Study title shortened, about 1 word
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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: 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? 3. 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: 1. Attend baseline and follow-up physiotherapy assessments. 2. Receive an individualized rehabilitation plan with education, pain and load monitoring, and home exercises. 3. Complete home exercises and keep a short symptom and activity log. 4. Attend in-person physiotherapy review visits during the rehabilitation period. 5. Answer questionnaires about pain, function, perceived change, and sports participation during follow-up.
Trial Details
NCT Number NCT07521280
Lead Sponsor Medical University of Gdansk
Conditions
(from sponsor)
Osgood-Schlatter Disease, Sever's Disease, Apophyseal Pain, Sinding-Larson and Johansson Syndrome (SLJ)
Related terms Osteochondrosis
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov