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

NCT07114731 | Completed

• 1 other identifier: IstanbulUC_IG
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Spastic Diplegia Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy; Neurodevelopmental Disorder (Diagnosis); Action Observation Therapy; Cerebral Palsy (CP); Action Observation

Keywords

Pediatric Rehabilitation; Neurodevelopmental Disorders; Cerebral Palsy; Action Observation Therapy; Neuroplasticity; Motor Learning; Children; Mirror Neuron System; Motor Function

Outcome Measures

Primary Outcomes (2)

• 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.

  2 days before treatment and 8 weeks

• 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.

  2 days before treatment and 8 weeks

Secondary Outcomes (6)

• Gross Motor Function Classification System

  2 days before treatment

• Gillette Functional Assessment Questionnaire (FAQ)

  2 days before treatment and 8 weeks

• 10-Meter Walk Test (10MWT)

  2 days before treatment and 8 weeks

• Five Times Sit to Stand Test

  2 days before treatment and 8 weeks

• Functional Reach Test (FRT)

  2 days before treatment and 8 weeks

Study Arms (2)

Neurodevelopmental treatment (NDT) + Synchronous Action Observation Therapy (AOT) Group

EXPERIMENTAL

Participants 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.

Other: Synchronous Action Observation Therapy

Neurodevelopmental treatment (NDT) + Asynchronous Action Observation Therapy (AOT) Group

EXPERIMENTAL

Participants 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.

Other: Asynchronous Action Observation Therapy

Interventions

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.

Neurodevelopmental treatment (NDT) + Synchronous Action Observation Therapy (AOT) Group

Asynchronous Action Observation Therapy OTHER

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

Neurodevelopmental treatment (NDT) + Asynchronous Action Observation Therapy (AOT) Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Unıversıty-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Cerebral palsy, spastic, diplegic; Neurodevelopmental Disorders; Disease

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 4, 2025
• Primary Completion: October 6, 2025
• Study Completion: October 20, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

TU (1)