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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neurodevelopmental treatment (NDT)
Feeding and oral-motor intervention strategies
Neck and trunk stabilization exercises
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Trunk Stabilization Exercises, Oral Motor, Quality of Life, Communication

Eligibility Criteria

18 Months - 54 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Group (SG)

Control Group (CG).

Arm Description

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).

(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).

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
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
Katz Index of Independence in Activities of Daily Living (ADL)
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.
Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4)
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.
Short Form 36 Questionnaire (SF-36)
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
Viking Speech Scale (VSS)
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.
Gross Motor Function Classification System (GMFCS)
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.
Communication Function Classification System (CFCS)
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

Secondary Outcome Measures

Full Information

First Posted
December 16, 2019
Last Updated
April 26, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04214080
Brief Title
Effect of Trunk Stabilization Exercises on Quality of Life and Communication in Cerebral Palsy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Trunk Stabilization Exercises, Oral Motor, Quality of Life, Communication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group (SG)
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group (CG).
Arm Type
Placebo Comparator
Arm Description
(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).
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental treatment (NDT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Feeding and oral-motor intervention strategies
Intervention Description
Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.
Intervention Type
Other
Intervention Name(s)
Neck and trunk stabilization exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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
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).
Title
Katz Index of Independence in Activities of Daily Living (ADL)
Description
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.
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).
Title
Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4)
Description
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.
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).
Title
Short Form 36 Questionnaire (SF-36)
Description
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
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).
Title
Viking Speech Scale (VSS)
Description
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.
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).
Title
Gross Motor Function Classification System (GMFCS)
Description
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.
Time Frame
Immediately before the intervention, the evaluation was performed in the first session (only one time).
Title
Communication Function Classification System (CFCS)
Description
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
Time Frame
Immediately before the intervention, an evaluation was performed in the first session (only one time).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim Ejraei, bachelor
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aysel Yıldız Ozer, Assoc. Prof.
Organizational Affiliation
Marmara University
Official's Role
Study Chair
Facility Information:
Facility Name
Marmara University Faculty of Health Sciences
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23596639
Citation
Ferluga ED, Archer KR, Sathe NA, Krishnaswami S, Klint A, Lindegren ML, McPheeters ML. Interventions for Feeding and Nutrition in Cerebral Palsy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. Report No.: 13-EHC015-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK132442/
Results Reference
background
PubMed Identifier
28533628
Citation
Shin JW, Song GB, Ko J. The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series. J Phys Ther Sci. 2017 Apr;29(4):771-774. doi: 10.1589/jpts.29.771. Epub 2017 Apr 20.
Results Reference
background
PubMed Identifier
24301008
Citation
Arvedson JC. Feeding children with cerebral palsy and swallowing difficulties. Eur J Clin Nutr. 2013 Dec;67 Suppl 2:S9-12. doi: 10.1038/ejcn.2013.224.
Results Reference
background
Links:
URL
https://www.ndta.org/
Description
The NDT/Bobath (Neuro-Developmental Treatment/Bobath) Definition.
URL
https://ibita.org/
Description
International Bobath Instructors Training Association

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

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