Cerebral PalsyNCT05792709
Effects of Oral Motor Therapy in Children With Cerebral Palsy
A study testing Oral Motor Therapy in people with Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
: CP is a neurodevelopmental condition. A set of irreversible impairments of movement and posture development, resulting in activity limitation. Acquired CP can be the outcome of a variety of issues that arise after the first 28 days of a baby's existence. A CP diagnosis can now be made as early as 16 weeks. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Oral Motor Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesPakistan
- Study dates
- 16 Aug 2022to 27 Feb 2023
- 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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CP children already diagnosed with feeding and swallowing difficulties.
- Age range: 4 to13 years
Who cannot join
- Patients with any co morbid conditions like uncontrolled epilepsy.
- Patients on NG or feeding tube.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Hafiza Shabnum Noor
Lahore, Punjab Province
Hafiza Shabnum Noor
Lahore
About this study
Official title: Effects of Oral Motor Therapy in Children With Cerebral Palsy ; A Randomized Control Trial
: CP is a neurodevelopmental condition. A set of irreversible impairments of movement and posture development, resulting in activity limitation. Acquired CP can be the outcome of a variety of issues that arise after the first 28 days of a baby's existence. A CP diagnosis can now be made as early as 16 weeks. speech-language pathologists (SLPs) began collaborating with OTs and PTs for Infants and toddlers who also struggle with speech impediments, feeding and swallowing disorder. Oral motor exercises (OMEs), also known as "mouth exercises," "non-speech oral motor training," and "oral motor treatment" were designed for their treatment. The objective of this study was to assess the effects of oral motor exercises in children with cerebral palsy having feeding and swallowing difficulties.
Read the detailed description
Over 17 million people throughout the world are living with cerebral palsy (CP), making it the most common physical disability among children. CP is a neurodevelopmental condition[1]. Cerebral palsy is a fitting classification of the condition and its associated deficits because the word cerebral means "pertaining to the brain" and palsy means "loss of muscle control." A set of irreversible impairments of movement and posture development, resulting in activity limitation, that are linked to non-progressive disruptions that occurred in the developing foetus or infant brain, was chosen as the official definition of CP in 2005 by the International Consensus [2]. It's important to keep in mind that the phrase "cerebral palsy" refers to a spectrum of conditions, each of which has its own unique appearance, set of symptoms, and prevalence rate within the general population. In addition to the musculoskeletal and neurological symptoms of CP, epilepsy and other sensory and cognitive impairments are also common
- Conditions
- Cerebral Palsy
- Being tested
- Oral Motor Therapy
- Keywords
- Oral Motor Therapy, Cerebral palsy, Drooling scale, Feeding and Swallowing
- 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 TherapyOther
Also called Traditional Therapy
In Traditional therapy we will give cognitive and articulation therapy to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Oral Motor Therapy | Experimental | These are exercises designed to increase the range of movement in tongue, lips, and jaw, which helped in speech and/or swallow functioning. It is important to move the designated area as far as can in each direction until feel the muscles stretch. Stop if feel any pain, and mention it to speech therapist or doctor. Practice these exercises, once through, 10 times a day. Receives: Other: Oral Motor Therapy |
| Traditional Therapy | Other | weeks traditional Speech Therapy was provided. Pre-language skills (vocalizations) manual sign languages, gestures, picture communication boards, voice output communication devices were used. Playing and talking, using pictures, books, objects, or ongoing events to help language development. Use of repetition exercises to build speech and language skills. Receives: Other: Oral Motor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding Oral Motor scale
This tool is used to evaluate the posture, jaw mobility, tongue activity, lips, feeding behavior, abnormal reflexes and breathing control
Measured: upto 16 weeks
Secondary outcomes (1)
Drooling severity and frequency scale
This tool is used to check the severity of drooling
Measured: upto 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start16 Aug 2022
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafiza Shabnum Noor, Riphah International University
- Investigators
- Ghazal Awais, MS-SLP, Principal investigator, Riphah International UniversityHafiza Shabnum Noor, MS-SLP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792709
- Sponsor's protocol ID
- REC/RCR & AHS/22/0646
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Turra GS, Schwartz IVD, Almeida ST, Martinez CC, Bridi M, Barreto SSM. Efficacy of speech therapy in post-intubation patients with oropharyngeal dysphagia: a randomized controlled trial. Codas. 2021 Apr 26;33(2):e20190246. doi: 10.1590/2317-1782/20202019246. eCollection 2021.
PubMed 33909759Sigan SN, Uzunhan TA, Aydinli N, Eraslan E, Ekici B, Caliskan M. Effects of oral motor therapy in children with cerebral palsy. Ann Indian Acad Neurol. 2013 Jul;16(3):342-6. doi: 10.4103/0972-2327.116923.
PubMed 24101813
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Motor Therapy in Children With Cerebral Palsy ; A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05792709
- Acronym / sponsor ID
- REC/RCR & AHS/22/0646
- Conditions
- Cerebral Palsy
- Keywords
- Oral Motor Therapy, Cerebral palsy, Drooling scale, Feeding and Swallowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 31 Mar 2023 (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.
: CP is a neurodevelopmental condition. A set of irreversible impairments of movement and posture development, resulting in activity limitation. Acquired CP can be the outcome of a variety of issues that arise after the first 28 days of a baby's existence. A CP diagnosis can now be made as early as 16 weeks. speech-language pathologists (SLPs) began collaborating with OTs and PTs for Infants and toddlers who also struggle with speech impediments, feeding and swallowing disorder. Oral motor exercises (OMEs), also known as "mouth exercises," "non-speech oral motor training," and "oral motor treatment" were designed for their treatment. The objective of this study was to assess the effects of oral motor exercises in children with cerebral palsy having feeding and swallowing difficulties.
Detailed description
Over 17 million people throughout the world are living with cerebral palsy (CP), making it the most common physical disability among children. CP is a neurodevelopmental condition[1]. Cerebral palsy is a fitting classification of the condition and its associated deficits because the word cerebral means "pertaining to the brain" and palsy means "loss of muscle control." A set of irreversible impairments of movement and posture development, resulting in activity limitation, that are linked to non-progressive disruptions that occurred in the developing foetus or infant brain, was chosen as the official definition of CP in 2005 by the International Consensus [2]. It's important to keep in mind that the phrase "cerebral palsy" refers to a spectrum of conditions, each of which has its own unique appearance, set of symptoms, and prevalence rate within the general population. In addition to the musculoskeletal and neurological symptoms of CP, epilepsy and other sensory and cognitive impairments are also common
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Motor Therapy | Experimental | Other: Oral Motor TherapyThese are exercises designed to increase the range of movement in tongue, lips, and jaw, which helped in speech and/or swallow functioning. It is important to move the designated area as far as can in each direction until feel the muscles stretch. Stop if feel any pain, and mention it to speech therapist or doctor. Practice these exercises, once through, 10 times a day. |
| Traditional Therapy | Other | Other: Oral Motor Therapyweeks traditional Speech Therapy was provided. Pre-language skills (vocalizations) manual sign languages, gestures, picture communication boards, voice output communication devices were used. Playing and talking, using pictures, books, objects, or ongoing events to help language development. Use of repetition exercises to build speech and language skills. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- CP children already diagnosed with feeding and swallowing difficulties.
- Age range: 4 to13 years
Key exclusion criteria (2 listed)
- Patients with any co morbid conditions like uncontrolled epilepsy.
- Patients on NG or feeding tube.
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 TherapyAlso: Traditional TherapyIn Traditional therapy we will give cognitive and articulation therapy to the patients. | Other | Oral Motor Therapy, Traditional Therapy |
Primary outcome
Feeding Oral Motor scale
Time frame: upto 16 weeks
This tool is used to evaluate the posture, jaw mobility, tongue activity, lips, feeding behavior, abnormal reflexes and breathing control
1 secondary outcome
Drooling severity and frequency scale
Time frame: upto 24 weeks
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 31 Mar 2023.
- Background: PubMed 33909759Turra GS, Schwartz IVD, Almeida ST, Martinez CC, Bridi M, Barreto SSM. Efficacy of speech therapy in post-intubation patients with oropharyngeal dysphagia: a randomized controlled trial. Codas. 2021 Apr 26;33(2):e20190246. doi: 10.1590/2317-1782/20202019246. eCollection 2021.
- Background: PubMed 24101813Sigan SN, Uzunhan TA, Aydinli N, Eraslan E, Ekici B, Caliskan M. Effects of oral motor therapy in children with cerebral palsy. Ann Indian Acad Neurol. 2013 Jul;16(3):342-6. doi: 10.4103/0972-2327.116923.
- Study ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Ghazal Awais, MS-SLP principal investigator
Riphah International University
Hafiza Shabnum Noor, MS-SLP principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Motor Therapy in people with Cerebral Palsy, run by Riphah International University at 2 sites 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 2 inclusion and 2 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Feeding Oral Motor scale (time frame: upto 16 weeks). 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 NCT05792709, which also lists 2 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 31 Mar 2023.