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IRCT20260321069007N5 IRCT 2026-09-11 Islamic Azad University Comparison of the Effectiveness of Calf and Ankle Myofascial Exercises Versus the Use of Nighttime AFO Brace in Skater Children with Achilles Tendon Shortening 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 2026-10-23 anticipated 36 Recruiting https://irct.ir/trial/91483 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 description: 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. N/A Achill Tendon Tightness. Intervention 1: Intervention group 1: Myofascial Release Exercise Group. Participants in this group will undergo a structured and progressive myofascial release exercise program for 6 weeks. The intervention will be performed three times per week, with each session lasting approximately 30 minutes under the supervision of a rehabilitation specialist. Each session consists of three phases: warm-up, myofascial release exercises, and cool-down. The warm-up includes light walking, ankle mobility exercises, and breathing exercises to increase blood flow and prepare the soft tissues. The myofascial release program targets the gastrocnemius, soleus, Achilles tendon complex, and plantar fascia using foam rollers, soft massage balls, and manual release techniques. The intensity and duration of the exercises are progressively increased throughout the intervention period. During the initial weeks, emphasis is placed on correct technique and reducing fascial tension, whereas in the later weeks the program incorporates active ankle movements, trigger-point release techniques, and functional movement activities. Each session concludes with diaphragmatic breathing and neuromuscular relaxation exercises for the calf muscles. Intervention 2: Intervention group 2: Night Ankle-Foot Orthosis (AFO) Group. Participants in this group will use a custom-made Night Ankle-Foot Orthosis (AFO) during sleep for 6 consecutive weeks. The orthosis will be individually fabricated according to each child's lower-limb measurements and designed to maintain the ankle in a neutral position, providing a sustained low-load stretch to the posterior calf muscles and the Achilles tendon complex. The nightly wearing time will be progressively increased, beginning with 3–4 hours per night during Weeks 1–2, increasing to 5–6 hours during Weeks 3–4, and reaching the entire sleep period (approximately 6–8 hours) during Weeks 5–6. Parents will record daily orthosis wear time using a monitoring log, and skin condition, comfort, and any adverse events will be monitored throughout the intervention. Intervention 3: Control group: Participants assigned to the control group will receive no myofascial release exercises or Night AFO intervention during the 6-week study period. They will continue their usual daily activities and regular skating practice without additional therapeutic interventions. Participants will also be instructed to avoid initiating any new rehabilitation exercises or orthotic treatments that could influence lower-limb function or Achilles tendon length during the study period. Pre-intervention and post-intervention assessments will be conducted under the same standardized conditions as those used for the intervention groups. Yes - There is a plan to make this available What will be shared: All potential data can be shared after de-identifying individuals When: Access period starts after publication of results To whom: Researchers working in academic and scientific institutions Conditions: Researchers at universities, such as faculty members, will be allowed to conduct any statistical and clinical analysis Where to obtain: Applicants can contact the responsible researcher by sending an email (razieh.yousefianmolla@iau.ac.ir) or calling (0098 9122022730). How to obtain: The researcher will receive the items within a maximum of two weeks after sending the email or making the phone call Comments:
public Razieh Yousefian Molla
Faculty of Physical Education and Sport Sciences, Velayat University Complex, Salman Street, Khandan Street, Ghaem Square, Artesh Boulevard, Sohanak
Tehran Iran (Islamic Republic of) 1955847781 +98 21 2248 1622 razieh.yousefianmolla@iau.ac.ir Islamic Azad University scientific Razieh Yousefian Molla
Faculty of Physical Education and Sport Sciences, Velayat University Complex, Salman Street, Khandan Street, Ghaem Square, Artesh Boulevard, Sohanak
Tehran Iran (Islamic Republic of) 1955847781 +98 21 2248 1622 razieh.yousefianmolla@iau.ac.ir Islamic Azad University Iran (Islamic Republic of) Presence of Achilles tendon tightness based on the Silfverskiöld test (passive ankle dorsiflexion range of motion less than 10 degrees). A minimum of 6 months of active participation and experience in skating. 8 years 12 years Female No history of injury or surgery History of other exercise programs or treatment interventions Lack of consent to participate in the study M67.0 Short Achilles tendon (acquired) Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Myofascial Release Exercise Group. Participants in this group will undergo a structured and progressive myofascial release exercise program for 6 weeks. The intervention will be performed three times per week, with each session lasting approximately 30 minutes under the supervision of a rehabilitation specialist. Each session consists of three phases: warm-up, myofascial release exercises, and cool-down. The warm-up includes light walking, ankle mobility exercises, and breathing exercises to increase blood flow and prepare the soft tissues. The myofascial release program targets the gastrocnemius, soleus, Achilles tendon complex, and plantar fascia using foam rollers, soft massage balls, and manual release techniques. The intensity and duration of the exercises are progressively increased throughout the intervention period. During the initial weeks, emphasis is placed on correct technique and reducing fascial tension, whereas in the later weeks the program incorporates active ankle movements, trigger-point release techniques, and functional movement activities. Each session concludes with diaphragmatic breathing and neuromuscular relaxation exercises for the calf muscles. Intervention group 2: Night Ankle-Foot Orthosis (AFO) Group. Participants in this group will use a custom-made Night Ankle-Foot Orthosis (AFO) during sleep for 6 consecutive weeks. The orthosis will be individually fabricated according to each child's lower-limb measurements and designed to maintain the ankle in a neutral position, providing a sustained low-load stretch to the posterior calf muscles and the Achilles tendon complex. The nightly wearing time will be progressively increased, beginning with 3–4 hours per night during Weeks 1–2, increasing to 5–6 hours during Weeks 3–4, and reaching the entire sleep period (approximately 6–8 hours) during Weeks 5–6. Parents will record daily orthosis wear time using a monitoring log, and skin condition, comfort, and any adverse events will be monitored throughout the intervention. Control group: Participants assigned to the control group will receive no myofascial release exercises or Night AFO intervention during the 6-week study period. They will continue their usual daily activities and regular skating practice without additional therapeutic interventions. Participants will also be instructed to avoid initiating any new rehabilitation exercises or orthotic treatments that could influence lower-limb function or Achilles tendon length during the study period. Pre-intervention and post-intervention assessments will be conducted under the same standardized conditions as those used for the intervention groups. Foot Pressure. Timepoint: Outcome measures will assess in two stages: a pre-test conducted before the start of the intervention and a post-test administered immediately after the completion of the 6-week training program. Method of measurement: Foot Scanner Device. Achill Tighness. Timepoint: Outcome measures will assess in two stages: a pre-test conducted before the start of the intervention and a post-test administered immediately after the completion of the 6-week training program. Method of measurement: Silverskiold. Spatial Temporal Gait Parameters. Timepoint: Outcome measures will be assessed in two stages: a pre-test conducted before the start of the intervention and a post-test administered immediately after the completion of the 6-week training program. Method of measurement: Foot Scanner Device. Balance. Timepoint: Outcome measures will assess in two stages: a pre-test conducted before the start of the intervention and a post-test administered immediately after the completion of the 6-week training program. Method of measurement: Foot Scanner Device. Islamic Azad University Approved 2026-04-07 Research Ethics Committees of Islamic Azad University- Central Tehran Branch Velayat University Complex, Salman Street, Khandan Street, Qaem Square, Artesh Boulevard, Sohanak. Tehran Tehran Iran (Islamic Republic of)