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

NCT ID: NCT04524559

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-12-31

Brief Summary

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.

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.

Conditions

Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

conventional physical therapy training

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

conventional physical therapy training

Intervention Type: OTHER

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.

oral motor training.

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Neurodevelopmental based training (NDT); Functional stretching exercises; Sequenced trunk co-activation (STA) exercises; - Righting and protective reactions:

Eligibility Criteria

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.

Exclusion Criteria

• Gum and/or dental problems
• Congenital problems of mouth and soft plate
• Uncontrolled seizures
• Any metabolic disorders
• Cardiopulmonary disorders
• Significant mental problems.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amira M Abd-elmonem, PHD

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sara s saad-Eldeen

Role: STUDY_DIRECTOR

MTI university, Egypt

Locations

faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

Oral Sensorimotor Stimulation

Identifier Type: -

Identifier Source: org_study_id