Comparison of the Effectiveness of Calf and Ankle Myofascial Exercises Versus the Use of Nighttime Ankle-Foot Orthosis on Gait Temporal Parameters, Plantar Pressure, and Balance in Skater Children with Achilles Tendon Shortening

Comparison of the Effectiveness of Calf and Ankle Myofascial Release Exercises Versus Night Ankle-Foot Orthosis on Spatiotemporal Gait Parameters, Plantar Pressure Distribution, and Balance in Young Skaters with Achilles Tendon Tightness

A single-blind, randomized, parallel-group, controlled clinical trial was conducted involving 36 patients. Randomization was performed using the RAND function in Microsoft Excel

Skiter swith achill tendon stiffness who refer to Akhtar Hospital in Tehran will be enrolled if eligible and randomly allocated to intervention and control groups using block randomization. The study will be single-blind, whereby the investigator and participants will be aware of the intervention type, while the outcome assessor and data analyst will be blinded to group allocation.

Inclusion criteria: Female skaters aged 8–12 years with at least 6 months of skating experience and Achilles tendon tightness. Exclusion criteria: History of surgery, unwillingness to participate in the study, or concurrent participation in other therapeutic interventions outside the study protocol.

Intervention Group 1 (Myofascial Release Exercise Group): 6-week myofascial release exercise program (3 sessions per week, 30 minutes). The program includes myofascial release techniques using foam rollers, soft massage balls, and manual techniques. Intervention Group 2 (Night AFO Group): Participants will use an AFO during sleep for 6 weeks. Intervention Group 3 (Control Group): Participants will receive no intervention.

Spatial-temporal gait parameter, Foot pressure, Balance

In this study, eligible participants who meet the inclusion and exclusion criteria and provide written informed consent will be randomly assigned to one of three groups: the Calf and Ankle Myofascial Exercises group, the Use of Nighttime AFO Brace group, or the Control group. The individual participant will serve as the unit of randomization. To ensure balanced group sizes, block randomization with variable block sizes will be employed. The random allocation sequence will be generated using Random Allocation Software with block sizes of six and nine. As the study consists of three groups, these block sizes were selected to maintain balanced allocation across groups within each block. For each block, all possible allocation arrangements among the three groups will be generated by the software, and the sequence of assignments will be determined completely at random. The randomization sequence will be generated by an individual who is not involved in the implementation of the study, and the researcher will have no role in either sequence generation or participant allocation. To maintain allocation concealment, group assignments will be placed in sequentially numbered, opaque, sealed envelopes according to the randomization sequence. Following participant enrollment and completion of baseline assessments, the appropriate envelope will be opened by the designated staff member, and the participant will be assigned to the corresponding study group.

Blinding in this study is limited to the outcome assessment level. Due to the nature of the interventions, participants are aware of the exercise program and orthosis they receive; therefore, participant blinding is not feasible. Likewise, the principal investigator, the therapist responsible for supervising the exercise program, and the clinician prescribing the orthosis are aware of group allocation and are actively involved in delivering the interventions. Consequently, blinding is not possible for these personnel. In contrast, all outcome assessments are performed by an independent assessor who has no access to participants' group allocation. Assessment data are provided using numerical identification codes only. During data collection and entry, coded identifiers are used, and no information regarding treatment allocation is disclosed to the outcome assessor. Data analysis is also conducted using coded datasets. No independent Data and Safety Monitoring Committee (DSMC) is established for this study. The investigators perform the primary data analysis using coded group labels, and treatment allocation remains concealed until completion of the primary analysis.

All potential data can be shared after de-identifying individuals

Access period starts after publication of results

Researchers working in academic and scientific institutions

Researchers at universities, such as faculty members, will be allowed to conduct any statistical and clinical analysis

Applicants can contact the responsible researcher by sending an email (razieh.yousefianmolla@iau.ac.ir) or calling (0098 9122022730).

The researcher will receive the items within a maximum of two weeks after sending the email or making the phone call