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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214080
• Other study ID #: 09.2018.337
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 5, 2019

Study information

• Verified date: May 2018
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 5, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 54 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Marmara University Faculty of Health Sciences	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK132442/ — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Primary	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.	Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Primary	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.	Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Primary	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	Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Primary	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.	Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Primary	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.	Immediately before the intervention, the evaluation was performed in the first session (only one time).
Primary	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	Immediately before the intervention, an evaluation was performed in the first session (only one time).

External Links

•   International Bobath Instructors Training Association
•   The NDT/Bobath (Neuro-Developmental Treatment/Bobath) Definition.