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

NCT ID: NCT04214080

Last Updated: 2020-05-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-05

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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).

Group Type EXPERIMENTAL

Neurodevelopmental treatment (NDT)

Intervention Type 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.

Feeding and oral-motor intervention strategies

Intervention Type OTHER

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

Intervention Type 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.

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).

Group Type PLACEBO_COMPARATOR

Neurodevelopmental treatment (NDT)

Intervention Type 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.

Feeding and oral-motor intervention strategies

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

54 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nasim Ejraei, bachelor

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Aysel Yıldız Ozer, Assoc. Prof.

Role: STUDY_CHAIR

Marmara University

Locations

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Marmara University Faculty of Health Sciences

Istanbul, Maltepe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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/

Reference Type BACKGROUND
PMID: 23596639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28533628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24301008 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.ndta.org/

The NDT/Bobath (Neuro-Developmental Treatment/Bobath) Definition.

https://ibita.org/

International Bobath Instructors Training Association

Other Identifiers

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09.2018.337

Identifier Type: -

Identifier Source: org_study_id

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