IRCT20260529069564N1 IRCT 2026-06-02 Gujranwala Institute of Medical and Emerging Sciences, Gujranwala, Pakistan Effects of Calf Muscle Stretches and Eccentric Exercises Along With Cryotherapy on Sever's Disease in Local Young Players of Gujranwala: A Randomized Clinical Trial None A single-blind randomized clinical trial comparing calf muscle stretches with cryotherapy, eccentric exercises with cryotherapy, and combined therapy on pain, functional disability, and ankle range of motion in young athletes with Sever’s disease 2025-06-01 anticipated 150 Complete https://irct.ir/trial/90497 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a three-arm, single-blind, parallel-group randomized controlled trial. Eligible participants with clinically diagnosed Sever's disease will be randomly allocated in a 1:1:1 ratio to one of three intervention groups: (1) calf muscle stretches with cryotherapy, (2) eccentric exercises with cryotherapy, or (3) combined calf muscle stretches and eccentric exercises with cryotherapy. Interventions will be administered three times weekly for six weeks. Outcome assessments will be conducted at baseline and after completion of the intervention period by an assessor blinded to group allocation. Primary outcomes include pain intensity and functional disability, while ankle range of motion will be assessed as a secondary outcome, Randomization description: Method of randomization: Not explicitly named (simple or block not specified), but participants were randomly assigned in a 1:1:1 ratio using an online tool Unit of randomization: Individual participant Randomization strata: None described Tools used for randomization: Online Research Randomizer tool (www.randomizer.org) How the random sequence was built: The tool generated the allocation sequence; unique identification codes were assigned to all participants Allocation concealment: Yes — outcome assessors were blinded to group allocation. However, participants and therapists could not be blinded due to the nature of exercise interventions, Blinding description: This study employed a single-blind design. Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded to group allocation. However, the assessor responsible for collecting outcome measures (pain intensity, functional disability, and ankle range of motion) will be blinded to treatment allocation throughout the study. Participants will be instructed not to disclose their assigned intervention to the assessor. In addition, data analysis will be conducted using coded group labels (e.g., Group A, B, and C) to maintain assessor and analyst blinding until the completion of statistical analyses. N/A Sever’s disease (calcaneal apophysitis) in physically active children and adolescents. Intervention 1: Intervention group:. Intervention 2: Intervention group:. Intervention 3: Intervention group:. Intervention 4: Control group:. Intervention 5: Control group:. Intervention 6: Control group:. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data (IPD) collected for all primary and secondary outcomes, including: NPRS pain scores, OXAFQ functional disability scores, and ankle range of motion measurements (dorsiflexion, plantar flexion, inversion, eversion) at baseline and 6 weeks post-intervention. Also includes demographic data (age, gender) and group allocation. When: Data will become available starting 6 months after publication of the main trial results and will remain available for 5 years. To whom: Data will be shared with researchers working in academic institutions who provide a methodologically sound proposal. Requests from commercial entities will be considered on a case-by-case basis. Conditions: Data may be used for systematic reviews, meta-analyses, secondary analyses of pediatric musculoskeletal conditions, and validation of outcome measures. Requests will be reviewed by the principal investigators (Dr. Shumana Zakaullah, Dr Saada Asif and Dr Sajjan Iqbal) based on scientific merit and ethical approval from the requester's institutional review board. Where to obtain: Requests should be directed to the corresponding author: Contact Person: Dr. Shumana Zakaullah Email: shumanazakaullah@gmail.com Address: Department of Physical Therapy, Gujranwala Institute of Medical and Emerging Sciences (GIMES), Ali Pur Chatha Road, near Gujranwala Medical College, Gujranwala, Punjab, 52250, Pakistan How to obtain: Applicants must submit a written request via email to the corresponding author, including a detailed research proposal, ethical approval letter, and signed data sharing agreement. Requests will be reviewed within 4–6 weeks. Approved applicants will receive deidentified data via secure encrypted file transfer. Comments: None