The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.

The Effects of Neurodevelopmental Therapy on Feeding and Swallowing Activities in Children With Cerebral Palsy.

Our study is planned to investigate the effects of neck and trunk stabilization exercises, which are structured from Neurodevelopmental therapy method-Bobath concept (NDT-B) principles, on feeding and swallowing activity in children with Cerebral Palsy (CP) who take feeding and oral motor intervention strategies. The cases were divided into two groups, which is the group receiving feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises (n=20) (Study Group) and those receiving feeding and oral motor intervention strategies (n=20) (Control Group).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Structured neck and trunk stabilization exercises; Other: Feeding and oral motor intervention strategies; Other: Caregiver training related to feeding

Detailed Description

Feeding and oral motor interventions address different aspects of feeding difficulties, reflecting the range in specific problems associated with feeding and nutrition in CP.

The trunk plays an important role in the organization of postural control and balance reactions because it holds the centre of all body mass and holds therefore, the centre of gravity. The trunk also provides stable attachment points to those muscles that control the head and neck regions. "Neck and trunk stabilization exercises" were the basis of static and dynamic balance abilities, and that increased neck and trunk stability might have had a positive effect thereon.

To achieve the alignment of the head with the trunk, the pelvis must be stabilized. This has important consequences for the entire process of swallowing. If the head is not stable, then the fine movements of the jaw and tongue needed for feeding will be impaired. With feeding and oral motor interventions and structured neck and trunk stabilization exercises, these parameters are positively affected.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Pendik
    • Istanbul, Pendik, Turkey, 0216 625 45 45/34899
      • Marmara University Pendik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cases with Cerebral Palsy who had difficulties in feeding/swallowing skills.
• Cases who were cooperative without communication barriers and volunteering to participate in the study were included.

Exclusion Criteria:

• In the Videoendoscopic Swallowing Study, he/she was not included in the study if he/she had an aspiration or aspiration risk, had advanced vision and hearing loss, used any pharmacological agent to inhibit spasticity, or had undergone orthopaedic surgery or Botulinum Toxin-A injection in the past six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group (SG); feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group)	Other: Structured neck and trunk stabilization exercises; Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.; Other: Feeding and oral motor intervention strategies; Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.; Other: Caregiver training related to feeding; In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
Placebo Comparator: Control Group (CG).; feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)	Other: Feeding and oral motor intervention strategies; Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.; Other: Caregiver training related to feeding; In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Classification System (GMFCS)	The gross motor functions of children with cerebral palsy were classified with GMFCS. GMFCS is a 5-level classification system. It uses gross motor skills. The aim is to present an idea of how self-sufficient a child can be at home, at school, and outdoor and indoor venues. GMFCS includes levels that reflect abilities ranging from unlimited walking (level I) to severe head and trunk control limitations. Requires extensive use of assisted technology and physical assistance, and wheelchair (level V). The higher level in GMFCS means a worse and severe outcome. The low levels mean good motor function.	Immediately before the intervention, the evaluation was performed in the first session (only one time).
the Eating and Drinking Ability Classification System (EDACS)	EDACS describes the eating and drinking skills of children with cerebral palsy from the age of 3. It is an ordered scale that defines the degree of assistance required during the meal and the individual's ability to eat and drink between five levels. Level I, safely and efficiently eating and drinking; at level V, it indicates unable to eat or drink safely, relies on tube feeding and is at high risk for aspiration.	Immediately before the intervention, the evaluation was performed in the first session (only one time).
the Mini-Manual Ability Classification System (Mini-MACS)	Mini-MACS is a functional classification that defines how children with cerebral palsy between the ages of 1 and 4 use their hands while holding objects in daily activities. Skill classes at five levels, based on the need for self-help and adaptation when children hold objects. Level I. Handles objects easily and successfully. Level V. Does not handle objects and has severely limited ability to perform even simple actions.	Immediately before the intervention, the evaluation was performed in the first session (only one time).
Trunk Impairment Scale (TIS)	TIS is a validated scale for cerebral palsy that evaluates the trunk functionally in terms of strength in a sitting position. It also complies with the International Classification of Functionality, Disability and Health in terms of evaluating the static and dynamic balance and trunk coordination of the trunk and the relationship between body function and structures. TIS consists of three subscales: static, dynamic and coordination. For each item; sequential scales with 2, 3 or 4 values are used. The highest scores that can be obtained from the static, dynamic and coordination subscales are; it is 7, 10 and 6 points. Total points are obtained by adding all subscales. The total TIS score ranges from 0 to 23. A high score indicates good trunk control.	Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Schedule for Oral Motor Assessment (SOMA)	SOMA is a measure which identifies "oral-motor dysfunction" (OMD). SOMA involves videotaping children and later assessing their feeding skills. Test was implemented in the presence of the child's main caregiver. The entire assessment lasted 20-30 minutes. SOMA has 7 subcategories. Each subcategory has its own cut-off point. Among the "yes" or "no" options opposite the observed parameters, the appropriate one is marked. In some options, the "yes" option indicates an abnormal function, while in some options the "no" option indicates the presence of an abnormal function. BOTTLE, TRAINER CUP, CUP(Cutting Score): ≥ 5 indicates OMD. < 5 indicates normal oral-motor function(OMF). PUREE: ≥ 3 indicates OMD. < 3 indicates normal OMF. SEMI-SOLIDS, SOLIDS: ≥ 4 indicates OMD. < 4 indicates normal OMF. CRACKER: ≥ 9 indicates OMD. < 9 indicates normal OMF. BOTTLE, CUP, PUREE, SOLIDS; minimum(mi) score: 0, maximum(ma): 9. TRAINER CUP; mi: 0, ma: 14. SEMI-SOLIDS; mi: 0, ma: 8. CRACKER; mi: 0, ma: 22.	Change from SOMA was assessed in 0 week (Baseline, in the first session, Before treatment), 6. week (6 weeks after treatment, in the 12th session, After treatment).
Pediatric Quality of Life Inventory (PedsQL)	The Quality of Life Scale for Children is a general quality of life scale which assesses the physical and psychosocial experiences independent of disease in children between the ages of 2 and 18 years. The scale is composed of 23 items. The items are scored between 0 and 100. The higher the score for the Quality of Life Scale for children, the better is the perception of health-related quality of life. In our study, the total score of the scale was used.	Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)	Instrumental evaluation of swallowing is a technique that allows the evaluation of swallowing physiology and anatomy in patients. The most commonly used form in the clinic is Flexible Fiberoptic Endoscopic Methods. The structures and functions related to swallowing are evaluated using through a fiberoptic tube extending from the nose to the pharynx. FEES allows direct visualization of some aspects of the pharyngeal phase. It gives information about the physiological changes that occur before and after swallowing. Since velopharyngeal closure occurs during swallowing, observation cannot be made. The pharynx, tongue root vallecula, pyriform sinuses, and residues formed after swallowing in the airway can be traced. There is no uniform decision to decide if a child should switch from oral feeding to enteral tube feeding, but there is a general consensus.	It was applied after the evaluation in the first session.

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Nasim EJRAEI, Master D, Marmara University; Study Director: Gonul Acar, Assoc. Prof, Marmara University

Publications and helpful links

General Publications

• Acar G, Ejraei N, Turkdogan D, Enver N, Ozturk G, Aktas G. The Effects of Neurodevelopmental Therapy on Feeding and Swallowing Activities in Children with Cerebral Palsy. Dysphagia. 2022 Aug;37(4):800-811. doi: 10.1007/s00455-021-10329-w. Epub 2021 Jun 25.

Helpful Links

• Feeding children with cerebral palsy and swallowing difficulties
• The importance of postural control for feeding.
• The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series
• The objective rating of oral-motor functions during feeding

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Neck-trunk stabilization exercise. Feeding. Swallowing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 09.2018.278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No