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IRCT20260730070445N1 IRCT 2026-08-27 University of social welfare and rehabilitation sciences Comparing the Effectiveness of Task-Oriented Training and Bimanual Therapy with Routine Occupational Therapy on Upper Limb Function in Children with Unilateral Cerebral Palsy Comparative Effectiveness of Task-Oriented Training and Bimanual Therapy versus Conventional Occupational Therapy on Upper Limb Function in Children with Unilateral Cerebral Palsy: A Randomized Clinical Trial Using Functional Assessments and Wearable Sensor–Based Objective Metric 2026-09-01 anticipated 50 Recruiting https://irct.ir/trial/92283 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is a three-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. Following confirmation of eligibility, participants will be assigned to one of three intervention groups (Task-Oriented Training, Bimanual Therapy, or Conventional Occupational Therapy) using stratified randomization based on Manual Ability Classification System (MACS) level (II or III) and the affected upper limb side (right or left). Outcome assessments will be conducted at baseline and immediately after completion of the intervention by independent assessors blinded to group allocation. In addition to standardized functional outcome measures, wearable inertial measurement unit (IMU) sensors will be used to obtain objective kinematic measures of upper limb function, Randomization description: After confirming eligibility and completing the baseline assessments, participants will be randomly assigned in a 1:1:1 allocation ratio to one of three intervention groups: Task-Oriented Training, Bimanual Therapy, or Conventional Occupational Therapy. Stratified randomization will be performed based on Manual Ability Classification System (MACS) level (II or III) and the affected upper limb side (right or left) to ensure a balanced distribution of these important prognostic factors across the study groups. Within each stratum, the random allocation sequence will be generated using R software with variable block sizes to maintain balanced group sizes while reducing the predictability of treatment assignment. The individual participant will be the unit of randomization. To ensure allocation concealment, Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) will be used. The envelopes will be prepared according to the randomization sequence by an individual who is independent of the recruitment, outcome assessment, and intervention processes. Following completion of the baseline assessments and confirmation of participant eligibility, the next consecutively numbered envelope will be opened to determine the participant's group assignment. This procedure will ensure that investigators and outcome assessors remain unaware of the allocation sequence until assignment, thereby minimizing the risk of prediction or manipulation of group allocation, Blinding description: To minimize assessment bias, two independent outcome assessors will be employed. Each assessor will be responsible for administering and scoring only one of the outcome measures (SFA or QUEST) and will remain blinded to participants' group allocation, the type of intervention received, and the results of the other assessor. In addition, participants and their parents/legal guardians will be instructed not to disclose any information regarding the intervention received during the assessment sessions. N/A Cerebral Palsy. Intervention 1: Intervention group: Task-Oriented Training Group: The task-oriented training intervention is based on principles of motor learning, activity-based practice, purposeful repetition, and problem-solving during meaningful activities. Children will practice a series of functional tasks related to daily living, school activities, and self-care, tailored to their abilities and functional goals. Task selection and progression will be individualized, with task difficulty gradually increased according to the child’s performance. During the sessions, the therapist will provide appropriate feedback and adjust the level of verbal guidance or physical assistance according to the child’s progress. Intervention 2: Intervention group: Bimanual Therapy Group: The intervention focuses on promoting coordinated and functional use of both hands during daily activities. Activities will be designed so that active participation of the affected upper limb is necessary for successful task completion. Tasks will include functional, play-based, educational, self-care, and object-manipulation activities, with the aim of improving bimanual coordination, increasing use of the affected upper limb, and reducing compensatory movement patterns. As in the task-oriented training group, task complexity will be progressively increased according to the child’s performance and progress. Intervention 3: Control group: Routine Occupational Therapy Group: Participants in this group will receive routine occupational therapy services according to the usual practices of the treatment centers. Interventions will be guided by the therapist’s clinical judgment and may include general range-of-motion exercises, strengthening exercises, fine motor activities, commonly used neuromuscular facilitation techniques, and motor coordination exercises. A structured task-oriented training or bimanual therapy protocol will not be used in this group; the type and sequence of activities will be determined according to the usual clinical practice of the treatment center.The intervention will be discontinued if requested by the parents, in the event of an adverse event, a change in the child’s medical condition, or excessive absenteeism. All groups will receive at least a standard level of occupational therapy care, and no participant will be deprived of effective treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the nature of the individual-level study data and confidentiality and data-protection considerations, particularly because the participants are children, there are no plans to publicly share or disseminate individual participant data. Study findings will be reported in aggregated form without identifying individual participants.
public Omid Rustamzadeh
kodakyar Ave, daneshjo Blvd, Evin, University of Social Welfare and Rehabilitation Sciences
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 kardarmangar.or@gmail.com University of social welfare and rehabilitation sciences scientific Nazila Akbarfahimi
kodakyar Ave, daneshjo Blvd, Evin, University of Social Welfare and Rehabilitation Sciences
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 nazilafahimi@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Medical diagnosis of unilateral cerebral palsy Absence of associated conditions such as visual impairment, Rett syndrome, ADHD, or autism spectrum disorder Manual Ability Classification System (MACS) level II or III Visual Function Classification System (VFCS) level I or II Age between 7 and 12 years No history of upper limb surgery or botulinum toxin injection within the past 6 months Ability to understand simple instructions and participate in treatment sessions No cognitive impairment based on the SPARKLE test Not receiving concurrent interventions similar to the study treatments during the study period Written informed consent obtained from parents/legal guardians and assent from the child 7 years 12 years Both Presence of a comorbid disease or condition that may affect motor function or participation in the study, such as uncontrolled seizures History of upper-limb surgery or botulinum toxin injection within the predefined period before study enrollment Concurrent participation in similar rehabilitation interventions Inability to understand simple instructions or participate safely and effectively in the treatment sessions Any medical condition that may prevent the child from participating safely in the study G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation Rehabilitation Intervention group: Task-Oriented Training Group: The task-oriented training intervention is based on principles of motor learning, activity-based practice, purposeful repetition, and problem-solving during meaningful activities. Children will practice a series of functional tasks related to daily living, school activities, and self-care, tailored to their abilities and functional goals. Task selection and progression will be individualized, with task difficulty gradually increased according to the child’s performance. During the sessions, the therapist will provide appropriate feedback and adjust the level of verbal guidance or physical assistance according to the child’s progress. Intervention group: Bimanual Therapy Group: The intervention focuses on promoting coordinated and functional use of both hands during daily activities. Activities will be designed so that active participation of the affected upper limb is necessary for successful task completion. Tasks will include functional, play-based, educational, self-care, and object-manipulation activities, with the aim of improving bimanual coordination, increasing use of the affected upper limb, and reducing compensatory movement patterns. As in the task-oriented training group, task complexity will be progressively increased according to the child’s performance and progress. Control group: Routine Occupational Therapy Group: Participants in this group will receive routine occupational therapy services according to the usual practices of the treatment centers. Interventions will be guided by the therapist’s clinical judgment and may include general range-of-motion exercises, strengthening exercises, fine motor activities, commonly used neuromuscular facilitation techniques, and motor coordination exercises. A structured task-oriented training or bimanual therapy protocol will not be used in this group; the type and sequence of activities will be determined according to the usual clinical practice of the treatment center.The intervention will be discontinued if requested by the parents, in the event of an adverse event, a change in the child’s medical condition, or excessive absenteeism. All groups will receive at least a standard level of occupational therapy care, and no participant will be deprived of effective treatment. Upper Extremity Skill Quality: Upper extremity movement quality and function will be assessed using the standardized Quality of Upper Extremity Skills Test (QUEST). The test evaluates four domains: dissociated movements, grasp, weight bearing, and protective extension. The total score ranges from 0 to 100%, with higher scores indicating better upper extremity skill quality and function. The assessment will be performed at two time points: before the intervention (baseline) and immediately after completion of the intervention (post-intervention). Timepoint: Following screening and informed consent, participants will undergo baseline assessment and will then be randomly allocated to one of three intervention groups. The interventions will be delivered for 4 weeks (3 sessions per week), with continuous monitoring throughout the intervention period. Outcome assessments will be conducted immediately after completion of the intervention (post-intervention) using the same assessment tools applied at baseline. Method of measurement: Measurement will be performed using the Quality of Upper Extremity Skills Test (QUEST). The test assesses upper extremity movement quality across four domains: dissociated movements, grasp, weight bearing, and protective extension. The total score ranges from 0 to 100%, with higher scores indicating better upper extremity function. School functioning will be assessed using the School Function Assessment (SFA), specifically the Activity Performance section. This section evaluates the child’s ability to perform school-related tasks and activities associated with the student role. Higher scores indicate better school functioning. The assessment will be performed at two time points: before the intervention (baseline) and immediately after completion of the intervention (post-intervention). Timepoint: The assessment will be performed at two time points: before the intervention (baseline) and immediately after completion of the intervention (post-intervention). Method of measurement: Section III (Physical Tasks) of the SFA questionnaire, completed by parents and teachers. Elbow/Forearm Angular Velocity: Angular velocity is defined as the rate of change in joint angle per unit of time during functional task performance and represents the speed of joint movement. It will be calculated from angular data recorded by wearable inertial measurement units (IMUs) placed on the upper arm and forearm. Angular velocity will be derived from the first derivative of the angular signal with respect to time and reported in degrees per second (°/s). This outcome will be measured at two time points: before the intervention (baseline) and immediately after completion of the intervention (post-intervention). Timepoint: This outcome will be measured at two time points: before the intervention (baseline) and immediately after completion of the intervention (post-intervention). Method of measurement: Angular velocity will be measured using inertial measurement unit sensors placed on the upper arm and forearm. Angular velocity will be calculated as the first derivative of the angular signal with respect to time and reported in degrees per second (°/s). Movement Symmetry Between the Upper Limbs: Movement symmetry refers to the similarity in movement patterns and the level of participation of the affected and less-affected upper limbs during the performance of functional bimanual tasks. This outcome will be assessed using data recorded by wearable inertial measurement units (IMUs) placed on the affected and less-affected upper limbs. The Asymmetry Index will be calculated to quantify the difference in movement between the two upper limbs and reported as a percentage (%). Lower Asymmetry Index values indicate greater movement symmetry and more similar participation of the two upper limbs. This outcome will be measured at two time points: before the intervention (baseline) and immediately after completion of the intervention (post-intervention). Timepoint: This outcome will be measured at two time points: before the intervention (baseline) and immediately after completion of the intervention (post-intervention). Method of measurement: Movement symmetry between the two upper limbs will be measured using inertial measurement unit sensors placed on the upper arm and forearm of both limbs. The Asymmetry Index will be calculated from the recorded movement data of the two limbs and reported as a percentage. Task Completion Time: The time required by the child to complete each functional task from task initiation to completion, calculated based on the onset and completion times extracted from IMU-recorded signals and reported in seconds. This outcome will be measured during selected tasks at baseline and immediately post-intervention. Timepoint: This outcome will be measured during selected tasks at baseline and immediately post-intervention. Method of measurement: Task completion time will be measured using inertial measurement unit sensors based on the timing of the recorded movement signals. The duration from the start to the completion of each task will be calculated and reported in seconds. Affected-Hand Use Ratio: The percentage contribution of the affected hand to the overall activity during a functional task, representing the extent to which the affected upper limb is used during task performance. This outcome will be calculated by extracting activity counts from the IMU signals recorded from both hands and determining the percentage ratio of activity in the affected hand to the total activity of both hands. The outcome will be measured at baseline and post-intervention and reported as a percentage (%). Timepoint: It will be measured at two times: before the intervention (Baseline) and immediately after the intervention (Post-intervention). Method of measurement: The affected hand use ratio will be measured using inertial measurement unit sensors placed on the upper arm and forearm of both upper limbs. The activity of each hand will be quantified based on the activity count extracted from the recorded movement signals, and the ratio of activity of the affected hand to the total activity of both hands will be calculated and reported as a percentage. Elbow/Forearm Movement Smoothness: The degree of smoothness and consistency of elbow and forearm movement during functional task performance, assessed using jerk-based metrics such as the Jerk Index or Spectral Arc Length. This outcome will be derived from angular movement data recorded by IMU sensors placed on the upper arm and forearm, and a movement smoothness index will be calculated for each selected task. Measurements will be performed at baseline and immediately post-intervention and reported as a normalized, unitless value. Timepoint: Measurements will be performed at two time points: before the intervention (Baseline) and immediately after the intervention (Post-intervention). Method of measurement: Elbow and forearm movement smoothness will be measured using inertial measurement unit sensors placed on the upper arm and forearm. Movement smoothness will be determined by analyzing the angular data and calculating the Jerk Index, reported as a normalized, dimensionless numerical value. University of social welfare and rehabilitation sciences Approved 2026-08-12 Ethics Committee of University of Social Welfare and Rehabilitation Sciences kodakyar Ave, daneshjo Blvd,Evin Tehran Tehran Iran (Islamic Republic of)