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Cerebral Palsy (CP)NCT07114731

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

A study testing Synchronous Action Observation Therapy and Asynchronous Action Observation Therapy in people with Cerebral Palsy (CP) and Spastic Diplegia Cerebral Palsy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 6 to 18 years
What is being tested?
Synchronous Action Observation Therapy and Asynchronous Action Observation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Aug 2025to 20 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Undergoing orthopedic surgery within the past 6 months
  • Presence of any additional systemic or neurological diseases
  • Missing three consecutive rehabilitation sessions

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Unıversıty-Cerrahpasa

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Comparison of the Effects of Synchronous and Asynchronous Action Observation Therapy on Balance, Walking and Functional Capacity 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.

Read the detailed description

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.

Being tested
Synchronous Action Observation Therapy, Asynchronous Action Observation Therapy
Keywords
Pediatric Rehabilitation, Neurodevelopmental Disorders, Cerebral Palsy, Action Observation Therapy, Neuroplasticity, Motor Learning, Children, Mirror Neuron System, Motor Function
Medical subject headings
Cerebral Palsy, Cerebral palsy, spastic, diplegic, Neurodevelopmental Disorders, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synchronous Action Observation TherapyOther

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

  • Asynchronous Action Observation TherapyOther

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

Study groups in NCT07114731
Study groupRoleWhat they receive
Neurodevelopmental treatment (NDT) + Synchronous Action Observation Therapy (AOT) GroupExperimentalParticipants in this group will receive a 20-minute Neurodevelopmental Training (NDT) session followed by synchronous Action Observation Therapy (AOT). The AOT component consists of four video modules: 1. Sitting position + Sit-to-Stand exercises 2. Weight-shifting exercises 3. Balance exercises 4. Walking exercises Participants will observe the videos in real-time and perform the movements simultaneously. The intervention will last for 8 weeks, with sessions conducted twice weekly for 45 minutes each.
Receives: Other: Synchronous Action Observation Therapy
Neurodevelopmental treatment (NDT) + Asynchronous Action Observation Therapy (AOT) GroupExperimentalParticipants in this group will receive the same 20-minute NDT session followed by asynchronous Action Observation Therapy (AOT). In this group, participants will first watch each of the four video modules, then perform the exercises afterward (i.e., not in real time). The intervention will last for 8 weeks, with sessions conducted twice weekly for 45 minutes each.
Receives: Other: Asynchronous Action Observation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 2 days before treatment and 8 weeks

  2. Pediatric Balance Scale (PBS)

    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.

    Measured: 2 days before treatment and 8 weeks

Secondary outcomes (6)
  1. Gross Motor Function Classification System

    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.

    Measured: 2 days before treatment

  2. Gillette Functional Assessment Questionnaire (FAQ)

    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.

    Measured: 2 days before treatment and 8 weeks

  3. 10-Meter Walk Test (10MWT)

    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.

    Measured: 2 days before treatment and 8 weeks

  4. Five Times Sit to Stand Test

    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.

    Measured: 2 days before treatment and 8 weeks

  5. Functional Reach Test (FRT)

    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.

    Measured: 2 days before treatment and 8 weeks

  6. Timed Get Up and Go Test (TUG)

    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.

    Measured: 2 days before treatment and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start4 Aug 2025
  3. Primary completion6 Oct 2025
  4. Study completion20 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07114731
Sponsor's protocol ID
IstanbulUC_IG
Status last verified
Mar 2026
First submitted
4 Aug 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Synchronous Action Observation Therapy and Asynchronous Action Observation Therapy in people with Cerebral Palsy (CP) and Spastic Diplegia Cerebral Palsy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gross Motor Function Measure - 88 (GMFM-88) - Dimensions D and E (time frame: 2 days before treatment and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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