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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04524559
Other study ID # Oral Sensorimotor Stimulation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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