search
Back to results

The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Structured neck and trunk stabilization exercises
Feeding and oral motor intervention strategies
Caregiver training related to feeding
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Neck-trunk stabilization exercise. Feeding. Swallowing

Eligibility Criteria

18 Months - 54 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Marmara University Pendik Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Group (SG)

Control Group (CG).

Arm Description

feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group)

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2020
Last Updated
November 15, 2020
Sponsor
Marmara University
search

1. Study Identification

Unique Protocol Identification Number
NCT04403113
Brief Title
The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.
Official Title
The Effects of Neurodevelopmental Therapy on Feeding and Swallowing Activities in Children With Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Neck-trunk stabilization exercise. Feeding. Swallowing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group (SG)
Arm Type
Experimental
Arm Description
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group)
Arm Title
Control Group (CG).
Arm Type
Placebo Comparator
Arm Description
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Intervention Type
Other
Intervention Name(s)
Structured neck and trunk stabilization exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Feeding and oral motor intervention strategies
Intervention Description
Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Intervention Type
Other
Intervention Name(s)
Caregiver training related to feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gross Motor Function Classification System (GMFCS)
Description
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.
Time Frame
Immediately before the intervention, the evaluation was performed in the first session (only one time).
Title
the Eating and Drinking Ability Classification System (EDACS)
Description
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.
Time Frame
Immediately before the intervention, the evaluation was performed in the first session (only one time).
Title
the Mini-Manual Ability Classification System (Mini-MACS)
Description
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.
Time Frame
Immediately before the intervention, the evaluation was performed in the first session (only one time).
Title
Trunk Impairment Scale (TIS)
Description
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.
Time Frame
Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Title
Schedule for Oral Motor Assessment (SOMA)
Description
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.
Time Frame
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).
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
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.
Time Frame
Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Other Pre-specified Outcome Measures:
Title
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Description
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.
Time Frame
It was applied after the evaluation in the first session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim EJRAEI, Master D
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gonul Acar, Assoc. Prof
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
0216 625 45 45/34899
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34173063
Citation
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.
Results Reference
derived
Links:
URL
https://www.nature.com/articles/ejcn2013224#citeas
Description
Feeding children with cerebral palsy and swallowing difficulties
URL
https://www.ncbi.nlm.nih.gov/pubmed/15185730
Description
The importance of postural control for feeding.
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5430291/
Description
The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series
URL
https://link.springer.com/article/10.1007/BF00260975
Description
The objective rating of oral-motor functions during feeding

Learn more about this trial

The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.

We'll reach out to this number within 24 hrs