Clinical trial NCT04403113: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Neck-trunk stabilization exercise. Feeding. Swallowing
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
measure: the Eating and Drinking Ability Classification System (EDACS)
timeFrame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
measure: the Mini-Manual Ability Classification System (Mini-MACS)
timeFrame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
measure: Trunk Impairment Scale (TIS)
timeFrame: Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
measure: Schedule for Oral Motor Assessment (SOMA)
timeFrame: 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).
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Secondary outcomes:
Other outcomes:
measure: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
timeFrame: It was applied after the evaluation in the first session.
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
state: Pendik
Study officials:
affiliation: Marmara University
name: Nasim EJRAEI, Master D
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Gonul Acar, Assoc. Prof
role: STUDY_DIRECTOR
References:
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.