The Effect of Action Observation Therapy on Spasticity, Motor Function, and Balance in Children With Cerebral Palsy

NCT07247331 | Completed

• 1 other identifier: suleymanedu//Myildiz001
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Spastic Diplegia Cerebral Palsy; Hemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Function measured by Gross Motor Function Measure-88 (GMFM-88)

  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 Outcomes (6)

• Change in muscle tone measured by Modified Ashworth Scale (MAS)

  Baseline and after 150 days

• Change in balance function measured by Pediatric Balance Scale (PBS)

  Baseline and after 150 days

• Change in dynamic balance measured by Pediatric Reach Test (PRT)

  Baseline and after 150 days

• Change in functional mobility measured by Timed Up and Go Test (TUG)

  Baseline and after 150 days

• Change in activity level measured by Goal Attainment Scale (GAS)

  Baseline and after 150 days

Study Arms (3)

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

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

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

Interventions

action observation therapy OTHER

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; Group 3; Treatment Program of the Control Group (Group 1):

Eligibility Criteria

• Age: 5 Years - 13 Years
• Gender Eligibility Details: men and women
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, Isparta, 32200, Turkey (Türkiye)

Location

Related Publications (2)

• Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.

  PMID: 29764869 RESULT

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Cerebral palsy, spastic, diplegic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• hatice yakut

  Suleyman Demirel University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: November 25, 2025
• Study Start: December 2, 2022
• Primary Completion: March 15, 2024
• Study Completion: July 7, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)