Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy

Feasibility Of Oral Sensorimotor Stimulation And Sequenced Trunk Co-Activation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy: A Randomized Controlled Trial

Children with CP encounter swallow and feeding impairments, especially in infancy and childhood with long meal times with late development of oral motor skills resulting in poor growth.

Study Overview

• Status: Completed
• Conditions: Physical Therapy
• Intervention / Treatment: Other: conventional physical therapy training; Other: oral motor training.

Detailed Description

this study will be conducted to explore the feasibility of oral sensorimotor stimulation combined with sequenced trunk co-activation on oropharyngeal dysphagia in children with spastic quadriplegic CP.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12662
    • Faculty of physical therapy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria

• Diagnosed as spastic quadrilepgic CP
• Both genders
• Aged from 12 to 48 months
• Scored ≤ 10 on an initial evaluation of Oral Motor Assessment Scale.
• Having at least a problem of oral motor functions (drooling, swallowing, and/or sucking); independent feeding
• Grade ≥ 2 spasticity according to the MAS
• Level IV and V motor function according to the GMFCS-R&E.
• Partial head and trunk control. Exclusion criteria
• Gum and/or dental problems
• Congenital problems of mouth and soft plate
• Uncontrolled seizures
• Any metabolic disorders
• Cardiopulmonary disorders
• Significant mental problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: conventional physical therapy training; received 90 minutes conventional physical therapy training focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms.	Other: conventional physical therapy training; The program focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms. The program was applied via certified physical therapists five days/week for 4 successive months. The intended goals of the treatment program were achieved through: Neurodevelopmental based training (NDT); Functional stretching exercises to preserve muscle and soft tissues elasticity; Sequenced trunk co-activation (STA) exercises; Righting and protective reactions It is worth mentioned that the exercises applied in each session was influenced by the age and the specific functional abilities within the selected activity.; Other Names: Neurodevelopmental based training (NDT); Functional stretching exercises; Sequenced trunk co-activation (STA) exercises; - Righting and protective reactions:
EXPERIMENTAL: oral stimulation; received 30 minutes of oral motor training five days week. The training included oral stimulation (facilitation) conducted before the child's actual meal time. The designed protocol comprised modified perioral and intraoral maneuvers based on Fucile's protocol	Other: conventional physical therapy training; The program focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms. The program was applied via certified physical therapists five days/week for 4 successive months. The intended goals of the treatment program were achieved through: Neurodevelopmental based training (NDT); Functional stretching exercises to preserve muscle and soft tissues elasticity; Sequenced trunk co-activation (STA) exercises; Righting and protective reactions It is worth mentioned that the exercises applied in each session was influenced by the age and the specific functional abilities within the selected activity.; Other Names: Neurodevelopmental based training (NDT); Functional stretching exercises; Sequenced trunk co-activation (STA) exercises; - Righting and protective reactions: Other: oral motor training.; Children in the experimental group received 30 minutes of oral motor training five days week. The training included oral stimulation (facilitation) conducted before the child's actual meal time. The designed protocol comprised modified perioral and intraoral maneuvers based on Fucile's protocol. The utmost aims of the protocol were to decrease hypersensitivity of oral structures, increase jaws movement, and reinforce muscle strength, improve tongue movement and enhance oral motor organization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral motor skills	The Oral Motor Assessment Scale is a reliable and accurate scale frequently used to assess oral-motor skills in young patients with neurological disorders. It is a useful tool that can be used in assessment and interventional studies. The full assessment takes approximately 20 minutes to be completed for each child giving score as passive (0), sub-functional (1), semi-functional (2) and functional (3) with higher scores represent better oral-motor skills	period of the treatment was 4 successive months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Physical growth	The body mass was measured via weight scale to detect the physical growth changes overtime.	period of the treatment was 4 successive months
- Segmental trunk control	The Segmental Assessment of Trunk Control (SATCo) was applied to assess upright trunk postural control in sitting position. It is an ordinal scale with a grade 1 to 7 is assigned for each segment with the score 7 indicates that the infant can't retain independent sitting (no hand support). A score of 8 is given as full trunk control is gained. Each infant would therefore have three scores to represent the static, active and reactive trunk control (higher scores represent better trunk control)	period of the treatment was 4 successive months
- Gross motor function	The motor function was conducted via the gross motor function measure (GMFM). The GMFM-88 is a valid and reliable observational criterion-referenced tool graded from 0-100 was developed to assess motor function in children with CP or Down syndrome. It measures gross motor function in five domains with 88 items with higher scores represent better motor function	period of the treatment was 4 successive months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: sara s saad-Eldeen, MTI university, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Oropharyngeal Dysphagia; Spastic Quadriplegia; Oral Sensorimotor Stimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Gastrointestinal Diseases; Musculoskeletal Diseases; Muscular Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Esophageal Diseases; Muscle Hypertonia; Cerebral Palsy; Deglutition Disorders; Muscle Spasticity
• Other Study ID Numbers: Oral Sensorimotor Stimulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No