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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Neurodevelopmental treatment (NDT); Other: Feeding and oral-motor intervention strategies; Other: Neck and trunk stabilization exercises

• Registration Number: NCT04214080
• Lead Sponsor: Marmara University

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.

Study Timeline

• Status Verified: 2018-05
• Study Start: 2018-05-01
• Primary Completion: 2019-05-31
• Study Completion: 2019-12-05
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2019-12-30
• Results First Submitted: 2020-02-25
• Results First Submitted QC: 2020-04-26
• Last Update Submitted: 2020-04-26
• Results First Posted: 2020-05-05
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group (SG)	Feeding and oral-motor intervention strategies	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).
Control Group (CG).	Neurodevelopmental treatment (NDT)	(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).
Control Group (CG).	Feeding and oral-motor intervention strategies	(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).
Study Group (SG)	Neck and trunk stabilization exercises	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).
Study Group (SG)	Neurodevelopmental treatment (NDT)	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Marmara University Faculty of Health Sciences; 🇹🇷 Istanbul, Maltepe, Turkey