Effect of Trunk Stabilization Exercises on Quality of Life and Communication in Cerebral Palsy

April 26, 2020 updated by: Marmara University

Evaluation of The Effect of Neck and Trunk Stabilization Exercises on Quality of Life and Communication in Children With Cerebral Palsy With Oral Motor Problem

To investigate the effectiveness of neck and trunk stabilization exercises on communication and quality of life (QoL) in children with cerebral palsy (CP) with oral motor problems. Children with CP were randomly divided into Study Group (SG) and Control Group (CG). Neurodevelopmental treatment (NDT) approaches and oral motor therapy were applied to both groups. SG also received neck-trunk stabilization training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the multidisciplinary approach, special approaches to secondary problems, oral-motor trainings and communication studies are used in addition to Neurodevelopment treatment approach in the treatment of children with CP. Because of their impact on postural control, neck-trunk stabilization exercises are very important for therapeutic interventions designed to improve quality of life with activities of daily living.

As the increases in neck muscle strength are related to trunk stabilization, trunk stabilization exercises are thought to have positive effects on neck muscle strength. In addition, since the neck and trunk are complementary to each other, it is supported by the literature that neck stabilization exercises and trunk stabilization exercises should be applied together.

Study Type

Interventional

Enrollment (Actual)

40

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
    • Maltepe
      • Istanbul, Maltepe, Turkey, 34000
        • Marmara University Faculty of Health Sciences

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

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.5 years and older,
  • Lack of cooperation problem to prevent communication,
  • To have been diagnosed with cerebral palsy and admitted to the hospital for routine control,
  • Volunteer to participate in the research,
  • Existence of at least one of the items of the "Key Questions" interrogation system showing feeding/swallowing problems in children with cerebral palsy.

Exclusion Criteria:

  • Presence of severe vision and hearing loss,
  • Use any pharmacological agent to inhibit spasticity,
  • He/she had undergone orthopedic surgery or Botulinum Toxin-A injection in the last six 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group (SG)

In addition to feeding and oral motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group.

Treatments were continued 2 days a week for 6 weeks (12 sessions).
Other: Neurodevelopmental treatment (NDT)
NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.
Other: Feeding and oral-motor intervention strategies
Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.
Other: Neck and trunk stabilization exercises
Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). All of these affect communication and quality of life.
Placebo Comparator: Control Group (CG).

(NDT-B) concept approaches and feeding and oral motor intervention strategies were applied to this group in routine treatment.

Treatments were continued 2 days a week for 6 weeks (12 sessions).
Other: Neurodevelopmental treatment (NDT)
NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.
Other: Feeding and oral-motor intervention strategies
Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
With VAS, families were asked to mark their communication status with their children. The definitions of the parameter to be evaluated are written on both ends of a 100 mm line. (0= no communication; 10= best communication). According to scale, the higher scores mean a better communication status
Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Katz Index of Independence in Activities of Daily Living (ADL)
Time Frame: Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Measures the capacity of a child to perform the activities that he/she has to do frequently in his/her daily life. The index has 6 questions. The patient gets 1 point if he/she makes each item independently; 0 points if he/she makes dependent. In the total score, 6 points indicate that patient is independent and 0 points indicate that patient is fully dependent. Higher Katz Index score means the better Activities of Daily Living.
Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4)
Time Frame: Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
It is a quality of life scale that measures health-related quality of life of children. It consists of 21 items. Items are scored between 0-100. The higher total score means a better health-related quality of life.
Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Short Form 36 Questionnaire (SF-36)
Time Frame: Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Quality of life of mothers was assessed by using the short form 36 questionnaire. It evaluates 8 sub-parameters, consisting of 36 items. 0= poor quality of life; 100= good quality of life. The higher score means a better health-related quality of life
Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Viking Speech Scale (VSS)
Time Frame: Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
This scale has been developed to classify children's speech production. The scale has 4 levels. (Level 1= Speech is not affected by motor disorder; 4= No understandable speech). The low scores mean good speech production.
Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Gross Motor Function Classification System (GMFCS)
Time Frame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
The gross motor function of children with cerebral palsy can be categorised into 5 different levels for the clear description of a child's current motor function. The higher level in GMFCS, means a worse and severe outcome. (Level I = Children walk without any limits; Level V= Children are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements). The low levels means good motor function.
Immediately before the intervention, the evaluation was performed in the first session (only one time).
Communication Function Classification System (CFCS)
Time Frame: Immediately before the intervention, an evaluation was performed in the first session (only one time).

CFCS provides 5 levels (CFCS I, II, III, IV, V) to describe everyday communication performance. The higher level in CFCS means a worse and severe outcome. Level 1= effective sender and receiver with unfamiliar and familiar partners; level 5=seldom effective sender and receiver even with familiar partners.

Low levels mean good communication performance
Immediately before the intervention, an evaluation was performed in the first session (only one time).

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Principal Investigator: Nasim Ejraei, bachelor, Marmara University
  • Study Chair: Aysel Yıldız Ozer, Assoc. Prof., Marmara 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

Helpful Links

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)

May 1, 2018

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

December 5, 2019

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 27, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

April 26, 2020

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2018.337

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.

Clinical Trials on Cerebral Palsy

Clinical Trials on Neurodevelopmental treatment (NDT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe