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IRCT20260321069007N3 IRCT 2026-06-13 Islamic Azad University The Effects of SPARK Training on Adolescents with Autism The Effects of a SPARK Training Program on Balance and Motor Performance in Adolescents with Autism 2026-06-22 anticipated 30 Complete https://irct.ir/trial/90766 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after identifying eligible participants based on the inclusion and exclusion criteria and obtaining written informed consent from parents or legal guardians, participants will be randomly assigned to either the “SPARK training group” or the “control group.” The unit of randomization in this study is the individual. To ensure balance in the number of participants between the two groups, simple randomization will be used based on a random number table. The random allocation sequence will be generated using Random Allocation Software or a random number table. In this method, each participant will be assigned a code, and based on the software output, individuals will be randomly allocated to one of the two study groups. The allocation sequence will be generated by an independent person who is not involved in the implementation of the study, and the researcher will have no role in the sequence generation or group assignment process. To ensure allocation concealment, the group assignment for each participant will be placed in sealed, opaque, and sequentially numbered envelopes. After completion of the baseline assessments (pre-test), the envelope corresponding to each participant will be opened by the responsible person, and the participant’s group allocation will be revealed. This procedure ensures that the allocation process cannot be predicted or manipulated by the researcher, Blinding description: In this study, blinding will be implemented in a limited manner and only at the level of outcome assessment. Due to the nature of the intervention (the SPARK exercise program), full blinding of participants and the intervention provider is not feasible; therefore, participants will be aware of the type of training program they receive, and blinding of participants will not be possible. In addition, the principal investigator and the exercise instructor will be informed of group allocation and will have a direct role in delivering the intervention; thus, blinding is not applied to them. In contrast, the outcome assessor (the individual responsible for measuring balance and motor function) will be blinded to participants’ group allocation and will have no access to information regarding the type of intervention. All assessments will be conducted using anonymized numerical codes, and the assessor will not be aware of whether participants belong to the control or SPARK training group. Where possible, the data analyst will also use de-identified coded data and perform statistical analyses without knowledge of group allocation in order to minimize potential bias in interpretation of the results. In this study, there is no independent Data Safety and Monitoring Committee (DSMC), and study oversight will be provided by the academic supervisor. The manuscript preparation and final reporting will also be based on coded datasets, and group allocation will remain concealed from unauthorized personnel until completion of the primary analysis. N/A Autism. Intervention 1: Intervention Group: SPARK Training Intervention Group. Participants in this group will undergo a structured SPARK-based training program for a period of 6 weeks. Training sessions will be conducted regularly (3 sessions per week, approximately 60 minutes per session) under the supervision of the researcher. The program is designed to improve physical fitness, motor performance, balance, and fundamental movement skills through structured, dynamic, and activity-based exercises. The main component of the intervention includes moderate-to-vigorous aerobic activities, agility training, group-based movement games, and fundamental movement skill exercises such as running, jumping, hopping, directional changes, and throwing/catching a ball. These activities will be progressively developed in terms of intensity, duration, and complexity over the 6 weeks. The exercises are designed to enhance active participation, motivation, and motor engagement while simultaneously improving neuromuscular coordination and motor control. During the sessions, simple equipment such as balls, cones, and low hurdles will be used to facilitate training tasks. Training load (including intensity, volume, and movement complexity) will be progressively increased throughout the intervention, starting with simpler and less demanding activities in the initial weeks and advancing toward more complex, faster-paced, and higher motor-control-demanding activities in the final weeks. Intervention 2: Control group: Participants in the control group will not engage in any structured exercise, rehabilitation program, or corrective training during the 6-week study period. They will be instructed to continue their usual daily activities and to refrain from initiating any new exercise programs, including strength training, balance training, stretching routines, or regular sports participation.To control for potential confounding factors, participants will be asked to maintain their habitual level of physical activity and avoid performing any targeted lower-limb exercise throughout the study period. No therapeutic intervention, training equipment, or rehabilitation procedures will be provided to this group. Baseline and post-intervention assessments will be conducted for these participants in the same manner as the intervention groups; however, no supervised training sessions will be held during the study period. 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
NO. 47, Ninth Street, Nafte Shomali Street, Zafer Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1919745638 +98 912 202 2730 razieh.yousefianmolla@iau.ac.ir Islamic Azad University scientific Razieh Yousefian Molla
NO. 47, Ninth Street, Nafte Shomali Street, Zafer Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1919745638 +98 912 202 2730 razieh.yousefianmolla@iau.ac.ir Islamic Azad University Iran (Islamic Republic of) Diagnosis of Autism Spectrum Disorder based on DSM-5 criteria Having Autism Spectrum Disorder with moderate to high functioning based on medical records and specialist evaluation Ability to participate in the SPARK training program 15 years 18 years Female No history of injury or surgery Participation in similar training programs during the past 3 months Lack of consent to participate in the study F84.0 Autistic disorder Rehabilitation Rehabilitation Intervention Group: SPARK Training Intervention Group. Participants in this group will undergo a structured SPARK-based training program for a period of 6 weeks. Training sessions will be conducted regularly (3 sessions per week, approximately 60 minutes per session) under the supervision of the researcher. The program is designed to improve physical fitness, motor performance, balance, and fundamental movement skills through structured, dynamic, and activity-based exercises. The main component of the intervention includes moderate-to-vigorous aerobic activities, agility training, group-based movement games, and fundamental movement skill exercises such as running, jumping, hopping, directional changes, and throwing/catching a ball. These activities will be progressively developed in terms of intensity, duration, and complexity over the 6 weeks. The exercises are designed to enhance active participation, motivation, and motor engagement while simultaneously improving neuromuscular coordination and motor control. During the sessions, simple equipment such as balls, cones, and low hurdles will be used to facilitate training tasks. Training load (including intensity, volume, and movement complexity) will be progressively increased throughout the intervention, starting with simpler and less demanding activities in the initial weeks and advancing toward more complex, faster-paced, and higher motor-control-demanding activities in the final weeks. Control group: Participants in the control group will not engage in any structured exercise, rehabilitation program, or corrective training during the 6-week study period. They will be instructed to continue their usual daily activities and to refrain from initiating any new exercise programs, including strength training, balance training, stretching routines, or regular sports participation.To control for potential confounding factors, participants will be asked to maintain their habitual level of physical activity and avoid performing any targeted lower-limb exercise throughout the study period. No therapeutic intervention, training equipment, or rehabilitation procedures will be provided to this group. Baseline and post-intervention assessments will be conducted for these participants in the same manner as the intervention groups; however, no supervised training sessions will be held during the study period. Static Balance. Timepoint: Outcome measures were 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: Strok Balance Test. Dynamic Balance. Timepoint: Outcome measures were 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: Walking Heel to Toe Test. Motor Performance. Timepoint: Outcome measures were 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: Bruininks–Oseretsky Test of Motor Proficiency (BOT-2). Islamic Azad University Approved 2026-05-23 Research Ethics Committees of Islamic Azad University- Karaj Branch Amir al-Mu’minin (A.S.) University Complex, Moazen Boulevard, Esteghlal Street Junction Rajaei Shahr (End), Karaj Alborz Province Iran Karaj Tehran Iran (Islamic Republic of)