Physical TherapyNCT04524559
Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy
A study testing conventional physical therapy training and oral motor training. in people with Physical Therapy, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 12 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Physical Therapy
- What is being tested?
- conventional physical therapy training and oral motor training.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Physical Therapy
- Being tested
- conventional physical therapy training, oral motor training.
- Keywords
- Spastic Quadriplegia, Cerebral Palsy, Oropharyngeal Dysphagia, Oral Sensorimotor Stimulation
- Medical subject headings
- Quadriplegia, Cerebral Palsy, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapy trainingOther
Also called Neurodevelopmental based training (NDT), Functional stretching exercises, Sequenced trunk co-activation (STA) exercises, - Righting and protective reactions:
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.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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: conventional physical therapy training; Other: oral motor training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: period of the treatment was 4 successive months
Secondary outcomes (3)
- Physical growth
The body mass was measured via weight scale to detect the physical growth changes overtime.
Measured: period of the treatment was 4 successive months
- 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)
Measured: period of the treatment was 4 successive months
- 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
Measured: period of the treatment was 4 successive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira M Abd-elmonem, PHD, Cairo University
- Investigators
- sara s saad-Eldeen, Study director, MTI university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524559
- Sponsor's protocol ID
- Oral Sensorimotor Stimulation
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04524559
- Acronym / sponsor ID
- Oral Sensorimotor Stimulation
- Conditions
- Physical Therapy
- Keywords
- Spastic Quadriplegia, Cerebral Palsy, Oropharyngeal Dysphagia, Oral Sensorimotor Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy training | Placebo comparator | Other: conventional physical therapy trainingreceived 90 minutes conventional physical therapy training focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms. |
| oral stimulation | Experimental | Other: conventional physical therapy training, Other: oral motor training.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 |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional physical therapy trainingAlso: Neurodevelopmental based training (NDT), Functional stretching exercises, Sequenced trunk co-activation (STA) exercises, - Righting and protective reactions: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 | conventional physical therapy training, oral stimulation |
| 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 | Other | oral stimulation |
Primary outcome
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
3 secondary outcomes
- Physical growth
Time frame: period of the treatment was 4 successive months
- Segmental trunk control
Time frame: period of the treatment was 4 successive months
- Gross motor function
Time frame: period of the treatment was 4 successive months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sara s saad-Eldeen study director
MTI university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy training and oral motor training. in people with Physical Therapy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral motor skills (time frame: period of the treatment was 4 successive months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.