Diplegic Cerebral Palsy and Action Observation Training

February 8, 2024 updated by: Burcu Talu, Inonu University

The Effect Of Video Based Action Observation Training And Live Action Observation Training On Motor Function, Activity Participation And Secondary Outcome Measures İn Children With Spastic Diplegic Cerebral Palsy

In this study, video-based action observation training and live action observation training in children with spastic diplegic cerebral palsy; It was aimed to examine the effect on motor function, activity participation and secondary outcome measures.

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

The study was designed as a single-blind randomized controlled trial. Patients aged 5-14 years with spastic diplegic cerebral palsy will be included. Children will be assigned to groups through stratified randomisation; The patients will be divided into 3 groups as experimental and control groups. Group 1 (experiment): video-based action observation training in addition to the conventional rehabilitation program, Group 2 (experiment): live action observation training in addition to the conventional rehabilitation program, Group 3 (control) will receive only the conventional rehabilitation program. The experimental group will receive 20 minutes of action observation training after a conventional physiotherapy program for 20 minutes for 8 weeks, 40 minutes 2 days a week. The control group will receive 40 minutes of conventional treatment. Evaluations will be made for each group, before and 8 weeks after the start of the study. GMFM for gross motor function; Pediatric berg balance scale for balance function; Timed Up and Go Test for functional mobility assessment; Gillette Functional Assessment Questionnaire and 1-min walk test to assess functional walking; sit and stand test for functional muscle strength and to evaluate activity participation; The Child and Adolescent Participation Questionnaire (CASP) will be used.

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.
Interventional

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.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Battalgazi/MALATYA
      • Malatya, Battalgazi/MALATYA, Turkey, 44280
        • Inonu 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

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with spastic diplegic cerebral palsy,
  • To be between the ages of 5-14,
  • To be at GMFCS I, II and III levels,
  • To have the cognitive level to follow the instructions given by the researchers,
  • IQ> 70 (to be accessed from patient files),
  • Those who do not have serious restrictions in joint movement,

Exclusion Criteria:

  • Children with joint contractures,
  • Not having visual impairment and visual field defect,
  • Children who have had a seizure in the last 6 months or children who cannot be controlled despite seizure medication
  • Those who received botulinum injections 6 months before the study.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Grup I
Conventional physiotherapy program, Video-based action observation training
Other: Video Based Action Observation
Individuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program.
Other Names:
  • Conventional physiotherapy program
Other: Conventional physiotherapy program
Individuals in this group will only receive a conventional physiotherapy program.
Experimental: Grup II
Conventional physiotherapy program, Live Action Observation Training
Other: Conventional physiotherapy program
Individuals in this group will only receive a conventional physiotherapy program.
Other: Live Action Observation
Individuals in this group will receive live action observation training in addition to the conventional physiotherapy program.
Other Names:
  • Conventional physiotherapy program
Other: Grup III
Conventional physiotherapy program
Other: Conventional physiotherapy program
Individuals in this group will only receive a conventional physiotherapy program.

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
Gross Motor Function Measure
Time Frame: 8weeks
Gross Motor Function measure is used to evaluate Motor Functions
8weeks
The Child and Adolescent Scale of Participation (CASP)
Time Frame: 8weeks
The CASP questionnaire is a questionnaire that evaluates the individual's community participation in the home, school, neighborhood settings.
8weeks

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
Pediatric berg balance scale
Time Frame: 8weeks
The test is performed progressively from timed sitting balance to standing on one leg.
8weeks
Timed Up and Go Test (TUG)
Time Frame: 8weeks
It is a test that measures the mobility of the child and evaluates both dynamic and static balance.
8weeks
Gillette Functional Assessment Questionnaire
Time Frame: 8weeks
Gillette FDA is a self-reported or self-reported assessment. Gillette FDA; It includes the FDA Gait Scale, which classifies ambulation function at 10 levels, and the 22-item Skills Test assessing functional locomotor activity.
8weeks
One-Minute Walk Test
Time Frame: 8weeks
It is an inexpensive and user-friendly test that can be used to assess functional ability with the 1-minute fast walking test. During the test, children wear their comfortable clothes and shoes. Children who wear orthoses are evaluated with orthoses, and children who walk with a mobility aid are evaluated with mobility aids.
8weeks
Sit to Stand Test
Time Frame: 8weeks
The child is asked to get up from a chair without armrests and sit back down again, with his hips and knees flexed to 90 degrees and his feet in full contact with the ground. The time to sit and stand up to 5 times is determined by the stopwatch.
8weeks

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.
Inonu 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.
  • Principal Investigator: Burcu TALU, Assoc. Prof., Inonu University

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.
January 1, 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.
February 24, 2022

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.
October 31, 2022

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 13, 2022

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.
January 13, 2022

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.
January 26, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
February 9, 2024

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.
February 8, 2024

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.
April 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 2021/2663

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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