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

NCT04214080 | Completed Results

• 1 other identifier: 09.2018.337
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Trunk Stabilization Exercises; Oral Motor; Quality of Life; Communication

Outcome Measures

Primary Outcomes (7)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

Study Group (SG)

EXPERIMENTAL

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); Other: Feeding and oral-motor intervention strategies; Other: Neck and trunk stabilization exercises

Control Group (CG).

PLACEBO COMPARATOR

(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); Other: Feeding and oral-motor intervention strategies

Interventions

Neurodevelopmental treatment (NDT) OTHER

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.

Control Group (CG).; Study Group (SG)

Feeding and oral-motor intervention strategies OTHER

Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.

Control Group (CG).; Study Group (SG)

Neck and trunk stabilization exercises OTHER

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.

Study Group (SG)

Eligibility Criteria

• Age: 18 Months - 54 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Health Sciences

Istanbul, Maltepe, 34000, Turkey (Türkiye)

Location

Related Publications (3)

• 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/

  PMID: 23596639 BACKGROUND

• 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.

  PMID: 28533628 BACKGROUND

• 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.

  PMID: 24301008 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Cerebral Palsy; Communication

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Limitations and Caveats

The limitations of this study are small sample size and relatively short follow-up time.

Results Point of Contact

• Title: Assoc. Prof Aysel Yıldız Ozer
• Organization: Marmara University

aysel.yildiz@marmara.edu.tr

5334674433

Study Officials

• Nasim Ejraei, bachelor

  Marmara University

  PRINCIPAL INVESTIGATOR

• Aysel Yıldız Ozer, Assoc. Prof.

  Marmara University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 30, 2019
• Study Start: May 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: December 5, 2019
• Last Updated: May 5, 2020
• Results First Posted: May 5, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)