]>
IRCT20250726066634N1 IRCT 2025-10-14 Kharazmi University The effect of balance and cognitive balance exercises on improving balance and movements in children with cerebral palsy. Investigating the effect of adding cognitive training to balance exercises on gait, motor performance, balance, brain activation pattern, quality of life, and fall risk in children with cerebral palsy. 2025-10-17 anticipated 42 Complete https://irct.ir/trial/85510 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to three study groups using block randomization with fixed block size of 6 and an allocation ratio of 1:1:1. Considering the total sample size of 42 participants, randomization will be performed in 7 consecutive blocks (7×6=42). In each block: Two participants will be assigned to the cognitive–balance training group Two participants will be assigned to the specific balance training group Two participants will be assigned to the control group The random sequence will be generated using the website Randomizer (https://www.randomizer.org/). To ensure allocation concealment, each group assignment will be placed in opaque, sealed, and sequentially numbered envelopes. After confirming eligibility and obtaining written informed consent from the parents or legal guardians, each participant will be given an envelope by an independent person who is not involved in data collection or intervention implementation. The participant will then be assigned to the group indicated inside the envelope. This procedure ensures that participants enter the random sequence in a sequential and concealed manner, preventing any investigator or staff involved in the intervention or data collection from knowing the group assignment in advance, Blinding description: In this study, the outcome assessor will be blinded, so that they will not be aware of the participants’ group allocation. Participants, their parents, and the intervention administrators (therapists) will not be blinded, as it is necessary for them to perform and supervise the exercises. N/A cerebral palsy. Intervention 1: Intervention Group 1 (Balance-Specific Training – BST):Participants in this group receive specialized balance training, including transfer exercises, static balance, and dynamic balance activities. The purpose of these exercises is to strengthen motor skills and improve balance control to reduce the risk of falls. Each session lasts 60 minutes and is conducted three times per week for 8 weeks. The intensity and difficulty of the exercises are gradually adjusted based on the child’s abilities. Intervention 2: Intervention group: Intervention Group 2 (Cognitive-Balance Training):Participants in this group perform combined motor and cognitive exercises. The exercises include cognitive tasks performed simultaneously with balance activities to improve motor control, balance, and cognitive function. Each session lasts 60 minutes and is conducted three times per week for 8 weeks. The exercises gradually become more challenging to maximize the child’s progress. Intervention 3: Control group: This group does not receive any intervention and only undergoes assessments before and after the research period. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Since the participants in this study are children with cerebral palsy, their individual and performance data are highly sensitive and confidential. Sharing individual participant data, even in a de-identified form, may conflict with ethical principles of research involving children and vulnerable populations. Therefore, to protect participants’ privacy and ensure ethical integrity, there is no plan to share individual participant data (IPD).
public Nafise Bagheri
Isfahan - Mirdamad Street - Alley No. 35 - Esteghlal Dead End - Omid Apartment
Esfahan Iran (Islamic Republic of) 8136937668 +98 31 3236 1511 nafise.bagheri6411@gmail.com Kharazmi University scientific Malihe Haddadnejad
Tehran, Shahid Keshvari Complex, end of Shahid Hesari Street, end of Mirdamad, Faculty of Physical Education and Sports Sciences
Tehran Iran (Islamic Republic of) 1544733111 +98 21 2222 8001 m.hadadnezhad@yahoo.com Kharazmi University Iran (Islamic Republic of) Major inclusion criteria before randomization: - Diagnosis of spastic cerebral palsy (CP) by a specialist physician - Age range between 7 and 18 years - Ability to understand and perform the proposed exercises and research tests - No participation in a similar training program during the past three months - Written informed consent from parents or legal guardian - General good health (no severe chronic diseases or psychological disorders that prevent exercise participation) - Gross Motor Function Classification System (GMFCS) levels I and II 7 years 18 years Both Major exclusion criteria before randomization : - Any surgery or medical conditions that prevent participation in exercises - Lack of cooperation or unwillingness of the child or parents to participate in the study - Participation in similar training programs or other interventions that may interfere with study outcomes - Occurrence of severe cognitive or motor problems that prevent continuing the exercises G80.9 Cerebral palsy, unspecified Rehabilitation Rehabilitation Rehabilitation Intervention Group 1 (Balance-Specific Training – BST):Participants in this group receive specialized balance training, including transfer exercises, static balance, and dynamic balance activities. The purpose of these exercises is to strengthen motor skills and improve balance control to reduce the risk of falls. Each session lasts 60 minutes and is conducted three times per week for 8 weeks. The intensity and difficulty of the exercises are gradually adjusted based on the child’s abilities. Intervention group: Intervention Group 2 (Cognitive-Balance Training):Participants in this group perform combined motor and cognitive exercises. The exercises include cognitive tasks performed simultaneously with balance activities to improve motor control, balance, and cognitive function. Each session lasts 60 minutes and is conducted three times per week for 8 weeks. The exercises gradually become more challenging to maximize the child’s progress. Control group: This group does not receive any intervention and only undergoes assessments before and after the research period. Balance. Timepoint: Immediately before the intervention begins and immediately after the intervention ends. Method of measurement: Dynamic balance (TUG), static balance (modified Romberg), functional balance (PBS). Gait. Timepoint: Immediately before the intervention begins and immediately after the intervention ends. Method of measurement: Using 2D video analysis in Kinovea software (while walking). Gross Motor Function. Timepoint: Immediately before the intervention begins and immediately after the intervention ends. Method of measurement: Using the Gross Motor Function Measure-88 (GMFM-88) test, two of the five motor domains of this test (D to E) are measured. Brain activation pattern. Timepoint: Measurement of outcome variables is carried out in two time phases: 1- Before the start of the intervention (pre-test) 2- After the end of the intervention (post-test). Method of measurement: Using electroencephalography (EEG). Quality of life. Timepoint: Immediately before the intervention begins and immediately after the intervention ends. Method of measurement: Persian-translated CP QOL-Child Quality of Life Questionnaire (based on age, either the patient or the patient's parents fill it out) Two questionnaire models based on age range. Fall Risk. Timepoint: Immediately before the intervention begins and immediately after the intervention ends. Method of measurement: Fall risk using the Dynamic Gait Index (DGI) test. Kharazmi University Approved 2025-06-26 Ethics Committee of Kharrazmi University Kharazmi University, University Square, Shahid Beheshti Street, Karaj, Iran Tehran Tehran Iran (Islamic Republic of)