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Completed

NCT Number: NCT07114731

Comparison of Synchronous and Asynchronous Action Observation Therapy in Children With Cerebral Palsy

The aim of this study is to compare the effects of synchronous and asynchronous action observation therapy (AOT) on balance, gait, and functional capacity in children with cerebral palsy (CP). CP is a neurodevelopmental disorder characterized by impairments in motor skills, particularly motor control and postural balance. By examining the contributions of synchronous (real-time) and asynchronous (delayed) AOT methods to motor performance, this study seeks to identify the most effective therapeutic approach for this population.

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Key information

About this study

Cerebral palsy (CP) is defined as a non-progressive neurological disorder that arises during fetal development, the neonatal period, or early childhood and results in permanent motor impairments. Lesions in the central nervous system of children with CP lead to a range of musculoskeletal, neuromuscular, and sensory system problems, causing postural abnormalities, balance and coordination deficits, and limitations in mobility. These impairments significantly reduce independence in activities of daily living.

Various therapeutic approaches are utilized in the rehabilitation process to improve the functional independence of children with CP. According to the International Classification of Functioning, Disability and Health (ICF), rehabilitation interventions should be grounded in neuroplasticity-based principles to maximize functional outcomes. One such neuroplasticity-based approach that has gained increasing attention in recent years is Action Observation Therapy (AOT).

AOT is based on the mirror neuron theory, which posits that observing an action activates similar neural regions in the cerebral cortex as performing the action itself. This simultaneous activation facilitates action understanding, imitation, and motor learning, suggesting that AOT may be an effective intervention to enhance motor function in individuals with CP. Improving motor functions in children with CP is crucial to enhancing their participation in daily life activities and overall quality of life. In addition to conventional physiotherapy interventions, AOT has emerged in recent years as an effective rehabilitation strategy that supports neuroplasticity. AOT facilitates motor learning and skill acquisition by targeting the brain's mirror neuron system.

Although there is substantial evidence in the literature demonstrating that AOT improves upper extremity functions, studies systematically comparing its effects on balance, gait, and general functional capacity remain limited. In particular, the differential effects of synchronous and asynchronous AOT applications on various motor outcomes have not yet been thoroughly investigated. Understanding the mechanisms of action of these two approaches may contribute to the development of more individualized and tailored treatment programs for children with CP.

Moreover, the low cost and easy applicability of AOT increase its potential for clinical use. Therefore, the findings of this study could enhance the effectiveness of rehabilitation programs, offering more accessible treatment alternatives for both healthcare professionals and families. To address this gap in the literature, the present study aims to comprehensively investigate the effects of synchronous and asynchronous AOT on motor functions in children with CP.

In this study, both groups will receive neurodevelopmental treatment (NDT) for 20 minutes as part of their intervention program. In addition, participants in the synchronous AOT group will observe exercise videos divided into four components (1. Sitting posture and sit-to-stand exercises; 2. Weight-shifting exercises; 3. Balance exercises; 4. Gait exercises) and perform the observed movements simultaneously in real time. Conversely, the asynchronous AOT group will first observe each of these video segments for 3 minutes and then perform the corresponding exercises sequentially after observation. Each session will last 45 minutes, conducted twice a week for 8 weeks.

The exercise videos were developed to include 12 task-oriented exercises tailored to the GMFCS level and extremity involvement of the children. The exercises are designed with varying levels of difficulty to enhance functional skills and lower extremity performance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation of both the child and their family in the study
  • Diagnosis of cerebral palsy with spastic clinical type, including hemiparetic and diparetic distribution
  • Age between 6 and 18 years
  • Classified as Level I or II according to the Gross Motor Function Classification System (GMFCS)
  • Ability to comply with exercise interventions (based on medical report indicating normal mental level or "mild mental retardation")
  • Ability to understand and speak Turkish

Exclusion criteria

  • Presence of spasticity ≥3 in lower extremity muscle groups as measured by the Modified Ashworth Scale
  • Inability to cooperate with verbal commands
  • Presence of visual or hearing impairments
  • Diagnosis of epilepsy or current use of antiepileptic medications
  • Presence of joint contractures
  • Botulinum toxin injection to the lower extremities within the past 6 months
  • Undergoing orthopedic surgery within the past 6 months
  • Presence of any additional systemic or neurological diseases
  • Missing three consecutive rehabilitation sessions

Treatment and study plan

Synchronous Action Observation Therapy

Other

Real-time observation and execution of motor tasks through structured video modules designed based on participants' GMFCS level and extremity involvement.

Asynchronous Action Observation Therapy

Other

Observation of structured motor task videos followed by delayed execution, adapted to individual GMFCS levels and extremity involvement patterns.

Primary outcomes

  1. Gross Motor Function Measure - 88 (GMFM-88) - Dimensions D and E

    Time frame: 2 days before treatment and 8 weeks

    The GMFM-88 is a standardized observational instrument designed to measure changes in gross motor function in children with cerebral palsy. The scale consists of five dimensions:

    (A) Lying and rolling

    (B) Sitting

    (C) Crawling and kneeling

    (D) Standing

    (E) Walking, running, and jumping

    For this study, only Dimensions D and E will be assessed to evaluate standing and locomotor abilities. Each item is scored based on the child's ability to perform specific motor tasks. Scores can be calculated for each dimension separately as well as combined for a total score.

  2. Pediatric Balance Scale (PBS)

    Time frame: 2 days before treatment and 8 weeks

    The pediatric balance scale is a modified version of the Berg balance scale and is used to evaluate the functional balance ability of school-age children. The scale consists of 14 items, scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56.

Secondary outcomes

  1. Gross Motor Function Classification System

    Time frame: 2 days before treatment

    The Gross Motor Function Classification System (KMFSS) for CP is based on self-initiated movements with an emphasis on sitting, displacement and mobility. The main criterion when defining the five-level classification system is that the differences between the levels are meaningful in everyday life.

    General titles of each level LEVEL I: Walks without restrictions. LEVEL II: Walks with restrictions. LEVEL III: Walks using hand-held mobility devices. LEVEL IV: Self-movement is limited. Can use a motorized mobility vehicle. LEVEL V: Transported in a manual wheelchair.

  2. Gillette Functional Assessment Questionnaire (FAQ)

    Time frame: 2 days before treatment and 8 weeks

    The FAQ is a parent-reported tool designed to assess functional walking ability in children. It evaluates the level of independence and mobility in various daily walking activities, providing a global rating of walking performance.

  3. 10-Meter Walk Test (10MWT)

    Time frame: 2 days before treatment and 8 weeks

    The 10MWT is a timed performance test used to assess walking speed over a short distance. Participants are asked to walk a 10-meter path at their usual pace, and the time (in seconds) is recorded. The test is commonly used in pediatric populations with mobility limitations.

  4. Five Times Sit to Stand Test

    Time frame: 2 days before treatment and 8 weeks

    This test evaluates lower extremity functional strength and transitional movements. Participants are instructed to stand up and sit down five times consecutively as fast as possible from a standard chair without using their arms. The total time to complete the task is recorded.

  5. Functional Reach Test (FRT)

    Time frame: 2 days before treatment and 8 weeks

    The FRT assesses dynamic balance by measuring the maximal distance a participant can reach forward and sideways while standing in a fixed position without losing balance. A tape measure is mounted at shoulder height on the wall to track the reach distance.

  6. Timed Get Up and Go Test (TUG)

    Time frame: 2 days before treatment and 8 weeks

    It is a valid and reliable method used to evaluate functional mobility and static and dynamic balance in CP. From a starting position with hips, knees, and ankles flexed to 90°, participants get up from a chair without arm support, walk 3 meters, return and sit in the chair. The time starts to be recorded with the "go" prompt given by the evaluator and is stopped when the hip touches the chair.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Comparison of the Effects of Synchronous and Asynchronous Action Observation Therapy on Balance, Walking and Functional Capacity in Children With Cerebral Palsy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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