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N/A Completed N=40 Randomized Triple-blind Treatment

The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.

Source: ClinicalTrials.gov NCT04403113 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Gross Motor Function Classification System (GMFCS) — 4; 2; 0; 0 Participants

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).

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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