Action Observation Therapy in Hemiparetic CP: Impact on Balance & Lower Limb Function

April 16, 2025 updated by: Fatih Tekin

The Effect of Action Observation Therapy on Balance and Lower Extremity Function in Children With Hemiparetic Cerebral Palsy

Background:

Action Observation Therapy (AOT) leverages the mirror neuron system to enhance motor learning and is anticipated to improve upper extremity function in children with cerebral palsy. However, its effects on balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy remain underexplored. The planned study aims to evaluate whether the addition of AOT to conventional physiotherapy will positively influence balance, lower extremity function, and gait performance in this population.

Objective:

The study is designed to assess the efficacy of incorporating AOT as an adjunct to conventional physiotherapy in improving balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.

Methods:

A patient cohort consisting of children with hemiparetic cerebral palsy (GMFCS levels I and II) is planned to be assembled.

It is expected that a total of 20 patients will be recruited and then randomly allocated into an experimental group and a control group.

The experimental group is scheduled to receive conventional physiotherapy in addition to AOT sessions, while the control group is planned to receive conventional physiotherapy only.

The intervention period is planned for 6 weeks, during which both groups will participate in 12 physiotherapy sessions.

Additionally, the experimental group is scheduled to undergo AOT sessions twice weekly, with each session lasting 30 minutes.

Outcome measures to be employed will include the Timed Up and Go (TUG) test, Pediatric Balance Scale, Five-Step Stair Climbing and Descending Test, and the 6-Minute Walk Test (6MWT).

This study is expected to systematically evaluate the potential benefits of adding AOT to standard physiotherapy regimens for enhancing balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

    • Kınıklı
      • Denizli, Kınıklı, Turkey, 20070
        • Pamukkale University Faculty of Physiotherapy and Rehabilitation

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed hemiparetic type of cerebral palsy

Exclusion Criteria:

  • Any other types of cerebral palsy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
Conventional physiotherapy is a widely used therapeutic approach that focuses on improving physical function, mobility, and overall quality of life through evidence-based techniques. It typically includes exercises for strength, flexibility, balance, and coordination, along with manual therapy, postural training, and education about movement and body mechanics. This traditional method is commonly applied in the rehabilitation of patients with neurological, orthopedic, and musculoskeletal conditions. In pediatric populations, such as children with cerebral palsy, conventional physiotherapy plays a vital role in promoting motor development, enhancing functional independence, and preventing secondary complications.
Experimental: experimental

The AOT video comprised four specific tasks designed to improve lower extremity function, balance, and gait (Figure 1):

  1. Sitting Balance: Movements to enhance balance while seated (Figure 2).
  2. Sit-to-Stand Transition: Exercises to facilitate the transition from sitting to standing.
  3. Walking and Balance: Gait and balance training on a parallel bar or flat surface.
  4. Single-Leg Balance: Activities focused on improving balance on one leg. For each task, children observed the movement for 1 minute, then practiced the action for 5 minutes. A 1-minute rest period was allowed between tasks, with a total AOT session lasting 30 minutes. All sessions were conducted by the same physiotherapist.
Conventional physiotherapy is a widely used therapeutic approach that focuses on improving physical function, mobility, and overall quality of life through evidence-based techniques. It typically includes exercises for strength, flexibility, balance, and coordination, along with manual therapy, postural training, and education about movement and body mechanics. This traditional method is commonly applied in the rehabilitation of patients with neurological, orthopedic, and musculoskeletal conditions. In pediatric populations, such as children with cerebral palsy, conventional physiotherapy plays a vital role in promoting motor development, enhancing functional independence, and preventing secondary complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
The Timed Up and Go (TUG) Test is a simple and widely used clinical tool to assess a person's mobility, balance, and risk of falling. It involves timing a person as they rise from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete this sequence is recorded, with shorter times generally indicating better functional mobility. The TUG Test is commonly used in various populations, including older adults and individuals with neurological conditions such as stroke or cerebral palsy, to evaluate progress during rehabilitation or to identify individuals at risk of falls. It is valued for its ease of use, minimal equipment requirements, and ability to reflect real-world functional movements.
This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
Pediatric Balance Scale
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
A modified version of the Berg Balance Scale for children, the PBS consists of 14 items (maximum score 56). It assesses functional balance through activities such as sitting-to-standing, standing, transfers, stepping, single-leg stance, turning, bending, and reaching. The scale has demonstrated strong correlations with other functional measures in children with CP
This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
Five-Step Stair Climbing and Descending Test
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
This test evaluates functional mobility parameters including walking speed, strength, active joint range, and balance. Children are instructed to ascend and descend a 5-step staircase without pausing. The better of two trials is recorded; a shorter completion time indicates superior functional performance
This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
6-Minute Walk Test
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
Originally developed by Balke (1963), the 6MWT measures the distance walked in 6 minutes, reflecting the child's functional capacity for daily activities. In children with CP, typical distances range from 334 to 455 meters, varying according to sex, age, height, weight, and step length
This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.

Collaborators and Investigators

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

Sponsor

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)

January 10, 2023

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

December 10, 2024

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

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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