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NCT Number: NCT04524559

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

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.

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Key information

Conditions

Physical Therapy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Quadriplegia Signs and Symptoms

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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

Primary outcomes

  1. Oral motor skills

    Time frame: period of the treatment was 4 successive months

    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

Secondary outcomes

  1. - Physical growth

    Time frame: period of the treatment was 4 successive months

    The body mass was measured via weight scale to detect the physical growth changes overtime.

  2. - Segmental trunk control

    Time frame: period of the treatment was 4 successive months

    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)

  3. - Gross motor function

    Time frame: period of the treatment was 4 successive months

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2020
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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