The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy

August 9, 2023 updated by: melike özipek, Medipol University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The history and demographic information of all cases will be obtained.Action observation therapy will be applied to improve balance. The therapist will verbally explain the program to be applied to both groups. 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. Children with CP 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. The control group will be shown cartoons. After 3 minutes of monitoring, each exercise will be studied for 3 minutes. In order to increase the effectiveness of the action observation training, the participants will watch the video at the designated time in a quiet and noiseless place. 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 session will be repeated.

Physiotherapy program to be applied:

First week:

  • Double-leg balancing on soft ground with eyes open, hands free
  • Balance on both feet on soft ground with eyes closed, hands free
  • Stand on one leg with eyes open on hard ground
  • Stand on one leg on hard ground with eyes closed

Second week:

  • Standing with feet together on hard ground
  • Standing in tandem on hard ground
  • Right-left lower extremity weight transfer
  • Step forward in standing position

Third week:

  • Standing with feet together on soft ground
  • Standing in tandem on soft ground
  • Taking steps in different directions in a standing position
  • Kicking the ball with the foot Pre- and post-treatment fNIRS imaging will be used to measure the cerebral cortex blood supply of the participants. The registration will be taken from the fNIRS device (Medical Technologies LLC, Berlin, Germany) using the program NIRStar Acquisition (NIRx Medizintechnik GmbH, Germany). Records will be taken to scan the bilateral supplementary motor area over 8 sources and 4 receivers. NIRS registration will take place during action observation therapy and balance tests. In measuring balance with action observation therapy; Resting in sitting position for 20 seconds, watching action observation video while sitting for 20 seconds, standing on two legs on hard ground for 20 seconds, resting in sitting position for 20 seconds, will be repeated 6 times. For evaluation on soft ground, 20 seconds of resting on both feet with eyes open, 20 seconds of watching action observation video, 20 seconds of standing on two feet with eyes open, 20 seconds of resting on both feet with eyes open will be applied and fNIRS measurement will be performed by repeating 6 times. The same periods will be applied to the control group and a cartoon will be watched instead of the action observation video.

Study Type

Interventional

Enrollment (Estimated)

24

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 Contact

Study Contact Backup

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:

  • 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

Exclusion Criteria:

  • 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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: action observation therapy group
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
cartoon observation
No Intervention: control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric balance scale
Time Frame: 2 days before treatment and after 3 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross motor function classification system
Time Frame: 2 days before treatment

The Gross Motor Function Classification System (KMFSS) for CP is based on self-initiated movements with an emphasis on sitting, displacement and mobility. The main criterion when defining the five-level classification system is that the differences between the levels are meaningful in everyday life.

General titles of each level LEVEL I: Walks without restrictions. LEVEL II: Walks with restrictions. LEVEL III: Walks using hand-held mobility devices. LEVEL IV: Self-movement is limited. Can use a motorized mobility vehicle. LEVEL V: Transported in a manual wheelchair.
2 days before treatment
Gross motor function measurement-88
Time Frame: 2 days before treatment and after 3 weeks
Gross Motor Function Scale (GMFM-88) is divided into 5 main sections. It consists of a total of 88 items, 17 in the supine-prone position and turning section, 20 in the sitting section, 14 in the crawling-over-knee section, 13 in the standing section, and 24 in the walking-running-stair climbing section.
2 days before treatment and after 3 weeks
Lower Extremity Selective Control Evaluation Scale (SCALE)
Time Frame: 2 days before treatment and after 3 weeks
The evaluation method currently used in the evaluation of selective motor control of the lower extremity is SCALE. Hip, knee, ankle, subtalar joint and toes bilaterally; It scores between 0-2 points.
2 days before treatment and after 3 weeks
Trunk Impairment Scale
Time Frame: 2 days before treatment and after 3 weeks
The trunk impairment scale evaluates the trunk functionally in terms of strength in sitting position. The trunk impairment scale consists of three subsections: static, dynamic and coordination. The highest scores that can be obtained from the static, dynamic and coordination sub-headings are respectively; 7, 10 and 6 points. The total scale score ranges from 0 to 23.
2 days before treatment and after 3 weeks
Pediatric Outcome Data Collection Instrument (PODCI)
Time Frame: 2 days before treatment and after 3 weeks

PODCI is one of the scales with proven validity and reliability, which is prepared for both children and adolescents, and is frequently used to determine functional status and evaluate health-related quality of life. The scale has 3 different forms;

  1. PODCI child form: The section consisting of 86 questions is filled by the families of children aged 6-10.
  2. PODCI adolescent family form: The section consisting of 86 questions is filled by the families of adolescents aged 11-18.
  3. PODCI adolescent form: The section consisting of 83 questions is filled by adolescents between the ages of 11-18.

As a result, subscale standardized score "0" indicates worse health status and quality of life, "100" score indicates good health status and quality of life.
2 days before treatment and after 3 weeks
Nintendo Wii-Fit Balance Score
Time Frame: 2 days before treatment and after 3 weeks
After the demographic information of the patient is saved in the device system, the patient is shown how to place his/her foot on the Nintendo Wii Fit balance board, the weight ratio given to the right and left feet (Body Center of Gravity right and left) is evaluated by asking him to stand on the balance board without moving, and the data is recorded as a percentage.
2 days before treatment and after 3 weeks
Timed Get Up and Go Test (TUG)
Time Frame: 2 days before treatment and after 3 weeks
It is a valid and reliable method used to evaluate functional mobility and static and dynamic balance in CP. From a starting position with hips, knees, and ankles flexed to 90°, participants get up from a chair without arm support, walk 3 meters, return and sit in the chair. The time starts to be recorded with the "go" prompt given by the evaluator and is stopped when the hip touches the chair.
2 days before treatment and after 3 weeks
Functional Near Infrared Spectroscopy (fNIRS) Application
Time Frame: 2 days before treatment and after 3 weeks
fNIRS is one of the new methods used in the measurement of local cerebral blood flow. It provides information about brain activity in the measured region using optical scattering and absorption of light at wavelengths close to infrared (700-950 nm).
2 days before treatment and after 3 weeks

Collaborators and Investigators

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

Sponsor

Medipol 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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedipolUmelikeözipek

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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