NCT05995197

Brief Summary

type of study: clinical trial the goal of this study is to learn about action observation therapy for cerebral palsy population. The main question it aim to answer is: Is action observation therapy effective on balance in children with cerebral palsy? Twenty-four children who met the inclusion criteria in the study will be randomly divided into two groups as the training group(action observation group) and the control group.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

August 9, 2023

Last Update Submit

August 9, 2023

Conditions

Cerebral PalsyExercise Therapy

Keywords

action observation therapybalance

Outcome Measures

Primary Outcomes (1)

  • Pediatric balance scale

    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 after 3 weeks

Secondary Outcomes (8)

  • Gross motor function classification system

    2 days before treatment

  • Gross motor function measurement-88

    2 days before treatment and after 3 weeks

  • Lower Extremity Selective Control Evaluation Scale (SCALE)

    2 days before treatment and after 3 weeks

  • Trunk Impairment Scale

    2 days before treatment and after 3 weeks

  • Pediatric Outcome Data Collection Instrument (PODCI)

    2 days before treatment and after 3 weeks

  • +3 more secondary outcomes

Study Arms (2)

action observation therapy group

EXPERIMENTAL

Children will watch the action observation therapy video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. Children will watch the video of the exercise offered by the therapist and then practice the exercise. The watching time for each exercise is 3 minutes, and after watching 3 minutes, they will do the exercise in the video for 3 minutes.In order to increase the effectiveness of the action observation training. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, the evaluations at the beginning of the treatment will be repeated.

Other: action observation

control group

NO INTERVENTION

Children with CP will watch the video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. The therapist will explain the exercises verbally. Children will practice the exercise after watching cartoons. The watching time for each exercise is 3 minutes, and after watching 3 minutes of cartoons, they will do the exercise for 3 minutes. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, pre-treatment evaluations will be repeated.

Interventions

action observationOTHER

cartoon observation

action observation therapy group

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having been diagnosed with CP
  • To be at I and II levels according to the Gross Motor Function Classification System
  • Having bilateral and unilaterally affected spastic type CP
  • Cooperating with assessments
  • Absence of vision and hearing loss
  • According to the health board report, only motor skills are affected

You may not qualify if:

  • Botulinum toxin application in the last 6 months Having had any surgical operation in the last 6 months
  • Having dyskinetic, ataxic and hypotonic type CP
  • Not attending treatment sessions regularly for 2 weeks
  • Not participating in the pre- and post-treatment evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Abdelhaleem N, Taher S, Mahmoud M, Hendawy A, Hamed M, Mortada H, Magdy A, Raafat Ezz El-Din M, Zoukiem I, Elshennawy S. Effect of action observation therapy on motor function in children with cerebral palsy: a systematic review of randomized controlled trials with meta-analysis. Clin Rehabil. 2021 Jan;35(1):51-63. doi: 10.1177/0269215520954345. Epub 2020 Sep 9.

    PMID: 32907374RESULT

  • Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.

    PMID: 32570855RESULT

  • Jung Y, Chung EJ, Chun HL, Lee BH. Effects of whole-body vibration combined with action observation on gross motor function, balance, and gait in children with spastic cerebral palsy: a preliminary study. J Exerc Rehabil. 2020 Jun 30;16(3):249-257. doi: 10.12965/jer.2040136.068. eCollection 2020 Jun.

    PMID: 32724782RESULT

  • 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: 29764869RESULT

  • Sgandurra G, Biagi L, Fogassi L, Ferrari A, Sicola E, Guzzetta A, Tosetti M, Cioni G. Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study. Dev Neurobiol. 2020 Sep;80(9-10):351-360. doi: 10.1002/dneu.22783. Epub 2020 Oct 28.

    PMID: 32986904RESULT

  • Ozipek M, Saricaoglu M, Hanoglu L, Mutluay F. Action observation therapy effects on motor function and balance in cerebral palsy: an fNIRS-based randomized trial. Trials. 2025 Nov 3;26(1):465. doi: 10.1186/s13063-025-09181-2.

    PMID: 41184905DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Melike Özipek

CONTACT

+905448704190melikesen67@hotmail.com

Fatma Mutluay

CONTACT

+905333116782fmutluay@medipol.edu.tr

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 9, 2023

First Posted

August 16, 2023

Study Start

September 1, 2023

Primary Completion

September 30, 2024

Study Completion

January 30, 2025

Last Updated

August 16, 2023

Record last verified: 2023-08