Cerebral Palsy (CP)NCT06343922
Oral Motor Facilitation Technique And Traditional Exercises on Children With Cerebral Palsy
A study testing oral motor facilitation technique group and traditional oral motor exercises group in people with Cerebral Palsy (CP), run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- oral motor facilitation technique group and traditional oral motor exercises group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to Apr 2024
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with cerebral palsy
- Type: spastic CP
- Severity level :GMFCS (gross motor function classification scale) level III to V, with head and neck control problems
- With feeding and oral motor difficulties
- Gender male/female
- Age: 3-10 years
- No past history of receiving OMFT
Who cannot join
- CP children with other co morbidities or syndromes
- risk of aspiration
- children on tube feeding or with seizures
- children with craniofacial anomalies
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Mobilty Quest
Lahore, Punjab Province, 54000
Mobility Quest, 03336596656, mobilityquest@outlook.com
Nazia Mumtaz, PhD
About this study
Official title: Effects Of Oral Motor Facilitation Technique And Traditional Exercises On Drooling And Feeding Skills Of Children With Cerebral Palsy
Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.
Read the detailed description
Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- oral motor facilitation technique group, traditional oral motor exercises group
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral motor facilitation technique groupBehavioural
oral motor facilitation technique
traditional oral motor exercises groupOther
traditional oral motor exercises
| Study group | Role | What they receive |
|---|---|---|
| oral motor facilitation technique group | Experimental | Exercise by using OMFT protocol will be given in the order of warming up technique, key point technique and application technique for 30 min a day. Receives: Behavioral: oral motor facilitation technique group |
| traditional oral motor exercises group | Other | Traditional exercises of lips, cheeks, tongue and jaws will be provided for 30 min a day and 3 days/week Receives: Other: traditional oral motor exercises group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drooling
Change in drooling of CP children will be measured by using "Drooling Impact scale", a quantitative tool to evaluate the effects of intervention on drool control. It is a 10 item scale with 10 point scoring level from 0 (no impact at all) to 10 (severe impact) to quantify the impact of intervention.
Measured: 16 weeks
Change in feeding skills
A change in oral motor skills during feeding after intervention will be evaluated by using "Oral Motor Assessment Scale", a seven item/variable scale and each variable scores from 0 (not functional ) to 3 ( normal function). At the end total score is measured and an increase in score shows the improvement in feeding skills.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Dec 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Riphah International 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
- Model description
- Group 1 will receive exercises by using oral motor facilitation technique protocol three times a week Group 2 will receive traditional oral motor exercises three times per week
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazia Mumtaz, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343922
- Sponsor's protocol ID
- Sadaf Riphah
- Status last verified
- Apr 2024
- First submitted
- 26 Dec 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Widman-Valencia ME, Gongora-Meza LF, Rubio-Zapata H, Zapata-Vazquez RE, Lizama EV, Salomon MR, Estrella-Castillo D. Oral Motor Treatment Efficacy: Feeding and Swallowing Skills in Children with Cerebral Palsy. Behav Neurol. 2021 Oct 25;2021:6299462. doi: 10.1155/2021/6299462. eCollection 2021.
PubMed 34733374Min KC, Seo SM, Woo HS. Effect of oral motor facilitation technique on oral motor and feeding skills in children with cerebral palsy : a case study. BMC Pediatr. 2022 Nov 3;22(1):626. doi: 10.1186/s12887-022-03674-8.
PubMed 36324103Abd-Elmonem AM, Saad-Eldien SS, Abd El-Nabie WA. Effect of oral sensorimotor stimulation on oropharyngeal dysphagia in children with spastic cerebral palsy: a randomized controlled trial. Eur J Phys Rehabil Med. 2021 Dec;57(6):912-922. doi: 10.23736/S1973-9087.21.06802-7. Epub 2021 May 7.
PubMed 33960181Reid SM, Johnson HM, Reddihough DS. The Drooling Impact Scale: a measure of the impact of drooling in children with developmental disabilities. Dev Med Child Neurol. 2010 Feb;52(2):e23-8. doi: 10.1111/j.1469-8749.2009.03519.x. Epub 2009 Oct 15.
PubMed 19843155Ortega Ade O, Ciamponi AL, Mendes FM, Santos MT. Assessment scale of the oral motor performance of children and adolescents with neurological damages. J Oral Rehabil. 2009 Sep;36(9):653-9. doi: 10.1111/j.1365-2842.2009.01979.x. Epub 2009 Jul 15.
PubMed 19627455
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Oral Motor Facilitation Technique And Traditional Exercises On Drooling And Feeding Skills Of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06343922
- Acronym / sponsor ID
- Sadaf Riphah
- Conditions
- Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 3 Apr 2024 (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.
Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.
Detailed description
Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group 1 will receive exercises by using oral motor facilitation technique protocol three times a week Group 2 will receive traditional oral motor exercises three times per week
| Arm | Type | Receives |
|---|---|---|
| oral motor facilitation technique group | Experimental | Behavioral: oral motor facilitation technique groupExercise by using OMFT protocol will be given in the order of warming up technique, key point technique and application technique for 30 min a day. |
| traditional oral motor exercises group | Other | Other: traditional oral motor exercises groupTraditional exercises of lips, cheeks, tongue and jaws will be provided for 30 min a day and 3 days/week |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children with cerebral palsy
- Type: spastic CP
- Severity level :GMFCS (gross motor function classification scale) level III to V, with head and neck control problems
- With feeding and oral motor difficulties
- Gender male/female
Key exclusion criteria (4 listed)
- CP children with other co morbidities or syndromes
- risk of aspiration
- children on tube feeding or with seizures
- children with craniofacial anomalies
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 |
|---|---|---|
| oral motor facilitation technique grouporal motor facilitation technique | Behavioural | oral motor facilitation technique group |
| traditional oral motor exercises grouptraditional oral motor exercises | Other | traditional oral motor exercises group |
Primary outcome
Change in Drooling
Time frame: 16 weeks
Change in drooling of CP children will be measured by using "Drooling Impact scale", a quantitative tool to evaluate the effects of intervention on drool control. It is a 10 item scale with 10 point scoring level from 0 (no impact at all) to 10 (severe impact) to quantify the impact of intervention.
Change in feeding skills
Time frame: 16 weeks
A change in oral motor skills during feeding after intervention will be evaluated by using "Oral Motor Assessment Scale", a seven item/variable scale and each variable scores from 0 (not functional ) to 3 ( normal function). At the end total score is measured and an increase in score shows the improvement in feeding skills.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 34733374Widman-Valencia ME, Gongora-Meza LF, Rubio-Zapata H, Zapata-Vazquez RE, Lizama EV, Salomon MR, Estrella-Castillo D. Oral Motor Treatment Efficacy: Feeding and Swallowing Skills in Children with Cerebral Palsy. Behav Neurol. 2021 Oct 25;2021:6299462. doi: 10.1155/2021/6299462. eCollection 2021.
- Background: PubMed 36324103Min KC, Seo SM, Woo HS. Effect of oral motor facilitation technique on oral motor and feeding skills in children with cerebral palsy : a case study. BMC Pediatr. 2022 Nov 3;22(1):626. doi: 10.1186/s12887-022-03674-8.
- Background: PubMed 33960181Abd-Elmonem AM, Saad-Eldien SS, Abd El-Nabie WA. Effect of oral sensorimotor stimulation on oropharyngeal dysphagia in children with spastic cerebral palsy: a randomized controlled trial. Eur J Phys Rehabil Med. 2021 Dec;57(6):912-922. doi: 10.23736/S1973-9087.21.06802-7. Epub 2021 May 7.
- Background: PubMed 19843155Reid SM, Johnson HM, Reddihough DS. The Drooling Impact Scale: a measure of the impact of drooling in children with developmental disabilities. Dev Med Child Neurol. 2010 Feb;52(2):e23-8. doi: 10.1111/j.1469-8749.2009.03519.x. Epub 2009 Oct 15.
- Background: PubMed 19627455Ortega Ade O, Ciamponi AL, Mendes FM, Santos MT. Assessment scale of the oral motor performance of children and adolescents with neurological damages. J Oral Rehabil. 2009 Sep;36(9):653-9. doi: 10.1111/j.1365-2842.2009.01979.x. Epub 2009 Jul 15.
- 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.
Nazia Mumtaz, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral motor facilitation technique group and traditional oral motor exercises group in people with Cerebral Palsy (CP), run by Riphah International University at 1 site in Pakistan.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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 Pakistan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazia Mumtaz, Phd (03335196500, nazia.mumtaz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Drooling (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343922, which also lists 5 linked publications.
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 3 Apr 2024.