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

Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524559
• Other study ID #: Oral Sensorimotor Stimulation
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 48 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Deglutition Disorders
• Muscle Spasticity
• Physical Therapy

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	faculty of physical therapy, Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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
Secondary	- 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
Secondary	- 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