The Effect of Action Observation Therapy on Spasticity, Motor Function, and Balance in Children With Cerebral Palsy (AOT-CP)

November 20, 2025 updated by: Merve Yıldız, Suleyman Demirel University

Effect of Action Observation Therapy on Spasticity, Gross Motor Function, Balance And Participation in Children With Cerebral Palsy: A Randomized Controlled Study

In our randomized controlled study, which aims to investigate the contribution of Action Observation Therapy to rehabilitation by examining the effect of Action Observation Therapy on spasticity, gross motor function, balance and participation in children with spastic diplegic and hemiplegic cerebral palsy, the effectiveness of Action Observation Therapy to be applied in the home environment and accompanied by a physiotherapist will be investigated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, G*Power 3.1.3 program was used to calculate the minimum sample size in each group (control group (group 1), group 2 and group 3), in other words, the number of individuals in the groups. In this context, the effect size was taken as d = 1.1, the significance level was α = 0.05, and the minimum number of individuals in each group was calculated as 11 (33 in total) for a power of 0.80 (80%). Similar studies (Sgandurra 2013, Kim 2018) were taken into consideration in obtaining these parameters. The number of individuals in each group (+10%) was planned to be at least 12 (36 in total), taking into account individuals who were missing, incorrect or excluded from the study.

In order to prevent bias in terms of participants meeting the inclusion criteria, sociodemographic and clinical characteristics, criteria such as age, cerebral palsy type, GMFCS level and presence of comorbidities were taken into account in assigning individuals to groups in the study, and the stratified randomization method will be used. Accordingly, the age ranges are taken as 5-7, 8-10, 11-13, and the cerebral palsy type is; spastic diplegic and hemiplegic, GMFCS level; It will be taken as I-III and the stratification process will be done accordingly. Before the study, written and verbal "Informed Consent Form" will be obtained from the parents of all participants in the study and control groups. The content of the study will be explained to the children who will participate in the study in a way that the child can understand, and the child's consent will be obtained. After recording the sociodemographic data of the participants for both the experimental and control groups, their spasticity was measured by the Modified Ashworth Scale (MAS), their gross motor function levels were measured by the Gross Motor Function Measurement (GMFM), their participation was measured by the Child and Adolescent Participation Survey (CASP), and their balance was measured by the Timed Up and Go Test ( TUG), Pediatric Reach Test (PRT) and Pediatric Balance Scale (PDS), and the extent to which the individual goal has been achieved will be evaluated by the Goal Attainment Scale (GAS). Assessments will be administered the day before starting treatment, after completing the 6-week Action Observation Therapy, and after a 3-month follow-up period.

Treatment Program of the Control Group (Group 1): This group will not be shown any video clips, and general physiotherapy methods will be applied to their current needs, 2 sessions a week for 6 weeks. This method includes stretching exercises for spastic muscles, strengthening exercises for the antagonist of the spastic muscle, and stabilization exercises.

Group 2: Action Observation Therapy for the lower extremities will be applied to this group by their parents at home, 2 sessions a week for 6 weeks. Participants will be shown a video of a task by their parents at home. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip.

Group 3: Action Observation Therapy for the lower extremities will be applied by the therapist to this group, 2 sessions a week for 6 weeks. Participants will watch a video of a task presented by a therapist. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip. After each session of Action Observation Therapy, 20 minutes of physiotherapy will be applied towards the goals of 6 activities. The scope of physiotherapy to be applied will consist of activity-based exercises for the lower extremities, stepping, weight transfer, balance and functionality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Isparta
      • Isparta, Isparta, Turkey (Türkiye), 32200
        • Suleyman Demirel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

In order to prevent bias in terms of participants meeting the inclusion criteria, sociodemographic and clinical characteristics, criteria such as age, CP type, GMFCS level and presence of comorbidities were taken into account in assigning individuals to groups in the study, and the stratified randomization method will be used. Accordingly, the age ranges are taken as 5-7, 8-10, 11-13, and the CP type is; spastic diplegic and hemiplegic, GMFCS level; It will be taken as I-III and the stratification process will be done accordingly.

Description

Inclusion Criteria:

- 5-13 years old

  • Diagnosis of spastic hemiplegic and diplegic cerebral palsy
  • Gross Motor Function Classification System (GMFCS) Level I-III
  • Consent to participate in the study

Exclusion Criteria:

Exclusion criteria from the study:

  • Spastic hemiplegic and diplegic disease not associated with cerebral palsy
  • Presence of contractures affecting functional movement in the affected extremity
  • Presence of cardiopulmonary disease or severe visual and hearing impairments
  • Children who have had a seizure in the last 6 months
  • Children who have had any surgery or received botulinum injections within the last 6 months or during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Treatment Program of the Control Group (Group 1):
Treatment Program of the Control Group (Group 1): This group will not be shown any video clips, and general physiotherapy methods will be applied to their current needs, 2 sessions a week for 6 weeks. This method includes stretching exercises for spastic muscles, strengthening exercises for the antagonist of the spastic muscle, and stabilization exercises.
Other: action observation therapy
Action Observation Therapy (AOT) is among the neurorehabilitation approaches that enable motor learning by facilitating neuroplasticity. AOT is based on neuroscience and activation of the mirror neuron system. AOT occurs in the form of the observer following the motor action and performing the observed actions after observing the actions. AOT aims to improve different motor functions by providing motor learning through neuroplasticity activation.
Group 2
Action Observation Therapy for the lower extremities will be applied to this group by their parents at home, 2 sessions a week for 6 weeks. Participants will be shown a video of a task by their parents at home. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip.
Other: action observation therapy
Action Observation Therapy (AOT) is among the neurorehabilitation approaches that enable motor learning by facilitating neuroplasticity. AOT is based on neuroscience and activation of the mirror neuron system. AOT occurs in the form of the observer following the motor action and performing the observed actions after observing the actions. AOT aims to improve different motor functions by providing motor learning through neuroplasticity activation.
Group 3
Children with spastic hemiparetic and diparetic CP included in our study were asked to watch and then perform the 6 activities in the video recording on a 10.2-inch tablet screen. The EGT program was applied for 20 minutes per day, 2 sessions per week for 6 weeks. Since there is no definitive protocol for children with diparetic CP, the EGT program applied is compatible with the protocol described by Sgandurra et al. In the application, the patient was asked to watch the activities in the video clip under the supervision of a physiotherapist, and after a one-minute rest period following each viewing, to repeat these activities physically actively for the duration of the video. After each EGT session, a 20-minute physiotherapy session was applied with a physiotherapist for the targets of the 6 activities. The scope of the applied physiotherapy consisted of activity-based exercises for the lower extremity, such as taking steps, weight transfer, balance and functionality.
Other: action observation therapy
Action Observation Therapy (AOT) is among the neurorehabilitation approaches that enable motor learning by facilitating neuroplasticity. AOT is based on neuroscience and activation of the mirror neuron system. AOT occurs in the form of the observer following the motor action and performing the observed actions after observing the actions. AOT aims to improve different motor functions by providing motor learning through neuroplasticity activation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Gross Motor Function measured by Gross Motor Function Measure-88 (GMFM-88)
Time Frame: Baseline and after 150 days
Gross motor function will be assessed using the GMFM-88, which consists of five dimensions. The D (Standing) and E (Walking, Running, Jumping) dimensions will be used in this study. Each item is scored on a 0-3 scale, and total scores are expressed as a percentage. A higher score indicates better gross motor function. The change in GMFM-88 scores from baseline to 150 days after the intervention will be evaluated.
Baseline and after 150 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in muscle tone measured by Modified Ashworth Scale (MAS)
Time Frame: Baseline and after 150 days
Muscle tone will be assessed using the MAS, a 6-point ordinal scale (0-4 with 1+ as an intermediate grade) that measures resistance during passive muscle stretching in individuals with upper motor neuron lesions. A higher score indicates greater spasticity.
Baseline and after 150 days
Change in balance function measured by Pediatric Balance Scale (PBS)
Time Frame: Baseline and after 150 days
Balance function will be assessed using the PBS, which evaluates functional balance during activities requiring stability and transitions between postures. The total score ranges from 0 to 56, with higher scores indicating better balance performance.
Baseline and after 150 days
Change in dynamic balance measured by Pediatric Reach Test (PRT)
Time Frame: Baseline and after 150 days
Dynamic balance will be evaluated using the PRT, which measures the maximal reach distance in centimeters (forward, right, and left directions) while standing. Greater reach distance indicates better dynamic balance.
Baseline and after 150 days
Change in functional mobility measured by Timed Up and Go Test (TUG)
Time Frame: Baseline and after 150 days
Functional mobility will be assessed using the Timed Up and Go Test adapted for children with cerebral palsy. The time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded. A shorter time indicates better functional mobility.
Baseline and after 150 days
Change in activity level measured by Goal Attainment Scale (GAS)
Time Frame: Baseline and after 150 days
Activity levels will be assessed using the GAS, which measures achievement of individualized therapy goals. Each goal is rated on a 5-point scale from -2 (much less than expected) to +2 (much more than expected). A higher score reflects better goal attainment.
Baseline and after 150 days
Change in participation measured by Child and Adolescent Scale of Participation (CASP)
Time Frame: Baseline and after 150 days
Participation will be evaluated using the CASP, a caregiver-reported questionnaire assessing children's involvement in home, school, and community activities. The total score ranges from 0 to 100, with higher scores representing better participation.
Baseline and after 150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: hatice yakut, Suleyman Demirel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • suleymanedu//Myildiz001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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