N/A
N=40
The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT04403113 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Gross Motor Function Classification System (GMFCS) — 4; 2; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Structured neck and trunk stabilization exercises (Other); Feeding and oral motor intervention strategies (Other); Caregiver training related to feeding (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Marmara University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gross Motor Function Classification System (GMFCS) |
4; 2; 0; 0; 2; 0 | — |
| PRIMARY the Eating and Drinking Ability Classification System (EDACS) |
1; 0; 3; 1; 5; 7 | — |
| PRIMARY the Mini-Manual Ability Classification System (Mini-MACS) |
1; 1; 4; 3; 5; 5 | — |
| PRIMARY Trunk Impairment Scale (TIS) |
5.65; 2.90 | — |
| PRIMARY Schedule for Oral Motor Assessment (SOMA) |
2.10; 3.70; 3.75; 3.10; 2.05; 2.10 | — |
| PRIMARY Pediatric Quality of Life Inventory (PedsQL) |
48.42; 53.48 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT04403113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.