Back to resultsFeasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy
Primary Purpose
Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional physical therapy training
oral motor training.
Sponsored by
About this trial
This is an interventional treatment trial for Physical Therapy focused on measuring Spastic Quadriplegia, Cerebral Palsy, Oropharyngeal Dysphagia, Oral Sensorimotor Stimulation
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.
- 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.
Sites / Locations
- faculty of physical therapy, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
conventional physical therapy training
oral stimulation
Arm Description
received 90 minutes conventional physical therapy training focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
- Physical growth
The body mass was measured via weight scale to detect the physical growth changes overtime.
- 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)
- 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04524559
Brief Title
Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy
Keywords
Spastic Quadriplegia, Cerebral Palsy, Oropharyngeal Dysphagia, Oral Sensorimotor Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional physical therapy training
Arm Type
Placebo Comparator
Arm Description
received 90 minutes conventional physical therapy training focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms.
Arm Title
oral stimulation
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
conventional physical therapy training
Other Intervention Name(s)
Neurodevelopmental based training (NDT), Functional stretching exercises, Sequenced trunk co-activation (STA) exercises, - Righting and protective reactions:
Intervention Description
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
Intervention Name(s)
oral motor training.
Intervention Description
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 Outcome Measure Information:
Title
Oral motor skills
Description
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
Time Frame
period of the treatment was 4 successive months
Secondary Outcome Measure Information:
Title
- Physical growth
Description
The body mass was measured via weight scale to detect the physical growth changes overtime.
Time Frame
period of the treatment was 4 successive months
Title
- Segmental trunk control
Description
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)
Time Frame
period of the treatment was 4 successive months
Title
- Gross motor function
Description
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
Time Frame
period of the treatment was 4 successive months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sara s saad-Eldeen
Organizational Affiliation
MTI university, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
faculty of physical therapy, Cairo university
City
Giza
ZIP/Postal Code
12662
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy
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