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

NCT04524559 | Completed

• 1 other identifier: Oral Sensorimotor Stimulation
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Therapy

Keywords

Spastic Quadriplegia; Cerebral Palsy; Oropharyngeal Dysphagia; Oral Sensorimotor Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• - Physical growth

  period of the treatment was 4 successive months

• - Segmental trunk control

  period of the treatment was 4 successive months

• - Gross motor function

  period of the treatment was 4 successive months

Study Arms (2)

conventional physical therapy training

PLACEBO COMPARATOR

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

oral stimulation

EXPERIMENTAL

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; Other: oral motor training.

Interventions

conventional physical therapy training 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.

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

conventional physical therapy training; oral stimulation

oral motor training. 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

oral stimulation

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Quadriplegia; Cerebral Palsy; Deglutition Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• sara s saad-Eldeen

  MTI university, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: November 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)