Effects of Trunk Training in Patients With Cerebral Palsy

August 13, 2020 updated by: Derya Azim Rezaei, Okan University

The Comparison of Effectiveness of Structured Trunk Training Protocols in Patients With Cerebral Palsy

The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy. It is planned to include 45 patients with hemiparetic cerebral palsy between the ages of 5-15 and with Gross Motor Function Classification System (GMFCS) level I-III. Patients with cerebral palsy will be divided into 3 groups in a randomized controlled manner. Each group will continue and follow routine physiotherapy and rehabilitation treatments for 8 weeks. Then, structured trunk training will begin. NGT-based trunk training (45 minutes) to the first group, video-based trunk training (45 minutes) to the second group, and Video-based trunk training (45 minutes) will apply with Theratogs to the third group. Treatments will be applied two days a week for 8 weeks.

Study Type

Interventional

Enrollment (Anticipated)

45

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

  • Turkey
      • Istanbul, Turkey
        • Okan 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

Ages Eligible for Study

5 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with I-III levels according to Communication Function Classification System
  • Patients with I-III levels according to GMFCS
  • Patients with Hemiparetic Cerebral Palsy
  • Continuing regular physiotherapy and rehabilitation program for six months.

Exclusion Criteria:

  • Presence of visual or auditory impairment
  • Presence of epilepsy
  • Patients who have undergone orthopedic surgery in the last 6 months
  • Patients who received Botulinum Toxin-A injection in the last 6 months

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NGT Group
A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
Procedure: neurodevelopmental treatment
A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
ACTIVE_COMPARATOR: Video-based training group
Trunk training will be done with games developed for the use of children with cerebral palsy.
Procedure: video-based trunk training
Games developed for the use of children with cerebral palsy will be used for trunk training.
ACTIVE_COMPARATOR: Video-based training group with theratogs
Video-based trunk training (45 minutes) will apply with Theratogs to the group
Procedure: Video-based trunk training will apply with Theratogs
Video-based trunk training will apply with Theratogs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk Control Measurement Scale
Time Frame: 8 weeks
It will be used to evaluate trunk control in patients with CP.
8 weeks
Trunk Muscle Tone
Time Frame: 8 weeks
Trunk Muscle Tone will be evaluated with the Myoton®PRO device.
8 weeks
Segmental Assesment of Trunk Control Scale
Time Frame: 8 weeks
It is an evaluation method that allows the body control to be evaluated from 3 different aspects as static, active and reactive control, according to trunk control levels.
8 weeks
Balance Assessment System
Time Frame: 8 weeks
The Fizyosoft Balance Assessment system, which works in harmony with the Nintendo Wii Balance Board, will be used in the assessment of the sitting balance.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Berg Balance Scale
Time Frame: 8 weeks
It will be used to assess functional balance.
8 weeks
10-meters walking test
Time Frame: 8 weeks
It will be used to evaluate walking.
8 weeks
Gillette Functional Gait Assessment Questionaire
Time Frame: 8 weeks
It will be used to evaluate functional walking.
8 weeks

Collaborators and Investigators

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

Sponsor

Okan University

Investigators

  • Principal Investigator: Derya Azim Rezaei, MSc, Okan University,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
  • Study Director: Burcu Ersöz Hüseyinsinoğlu, Associate professor, Istanbul University-Cerrahpaşa,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

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)

July 21, 2020

Primary Completion (ANTICIPATED)

July 21, 2021

Study Completion (ANTICIPATED)

September 21, 2021

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (ACTUAL)

August 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Okan U

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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