The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.

NCT04403113 | Completed Results DMC

• 1 other identifier: 09.2018.278
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cerebral Palsy

Keywords

Neck-trunk stabilization exercise. Feeding. Swallowing

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

  It was applied after the evaluation in the first session.

Study Arms (2)

Study Group (SG)

EXPERIMENTAL

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; Other: Feeding and oral motor intervention strategies; Other: Caregiver training related to feeding

Control Group (CG).

PLACEBO COMPARATOR

feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)

Other: Feeding and oral motor intervention strategies; Other: Caregiver training related to feeding

Interventions

Structured neck and trunk stabilization exercises OTHER

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.

Study Group (SG)

Feeding and oral motor intervention strategies OTHER

Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.

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

Caregiver training related to feeding OTHER

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.

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

Eligibility Criteria

• Age: 18 Months - 54 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 0216 625 45 45/34899, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34173063 DERIVED

Related 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

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

In the study, it can be stated as the limitation of the study that all children with feeing problems are screened for only 40 cases and heterogeneous types are included in the study.

Results Point of Contact

• Title: Assoc. Prof Gonul Acar
• Organization: Marmara University

gonulacar34@gmail.com

5323778878

Study Officials

• Nasim EJRAEI, Master D

  Marmara University

  PRINCIPAL INVESTIGATOR

• Gonul Acar, Assoc. Prof

  Marmara University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: April 30, 2018
• Primary Completion: May 31, 2019
• Study Completion: October 15, 2019
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)