Clinical trial NCT04214080: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Trunk Stabilization Exercises
Oral Motor
Quality of Life
Communication
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
measure: Katz Index of Independence in Activities of Daily Living (ADL)
timeFrame: Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
measure: Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4)
timeFrame: Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
measure: Short Form 36 Questionnaire (SF-36)
timeFrame: Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
measure: Viking Speech Scale (VSS)
timeFrame: Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
measure: Communication Function Classification System (CFCS)
timeFrame: Immediately before the intervention, an evaluation was performed in the first session (only one time).
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Health Sciences
state: Maltepe
Study officials:
affiliation: Marmara University
name: Nasim Ejraei, bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Aysel Yıldız Ozer, Assoc. Prof.
role: STUDY_CHAIR
References:
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/
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.
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.