DroolingNCT04266626
Effectiveness of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia
A study testing kinesiotaping therapy and oral motor manipulation therapy in people with Drooling, run by Isra University at 1 site in Pakistan.
Trial summary
Children suffering from neurological problems may have a common problem of drooling and dysphagia.There is high prevelance of neurological disorders in developing countries including Pakistan.Parents of children with disability are highly stressed and burdenised while taking care of their children.there is a need to… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Drooling
- What is being tested?
- kinesiotaping therapy and oral motor manipulation therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to Sep 2020
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Both male and female children with different non degenerative neurological disabilities ( cerebral palsy, traumatice brain injury, childhood stroke) and having oral phase dysphagia.
- Age between 3-15 years.
- Those who will have drooling severity rating of ≥ 4 on modified Teacher's drooling scale.
- Child who can comprehend simple verbal commands and on 3 words sentence level speech
- Have good head control.
- Parents and care givers of children with drooling and oral phase dysphagia will also be included in the study
Who cannot join
- Those children who would have structural abnormality of respiratory system.
- Corrected or uncorrected cleft palate or cleft lip.
- Wounds around the lips.
- Recent surgery, and medication or on any treatment to control drooling would be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Romana Pervez
Abbottabad, Khyber Pakhtunkhwa, 22010
Romana Pervez, +923339867787, romo_virgo@hotmail.com
Abdul Haseeb Bhutta, +923479470947, abdulhaseeb@hhirs.edu.pk
About this study
Official title: Clinical and Psychological Outcomes of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia
Children suffering from neurological problems may have a common problem of drooling and dysphagia.There is high prevelance of neurological disorders in developing countries including Pakistan.Parents of children with disability are highly stressed and burdenised while taking care of their children.there is a need to overcome the drooling and dysphagia problems with effective interventions.
Read the detailed description
There is no clear consensus that which interventions are safe and effective and hard to decide about the effective intervention for drooling management. This will help the parents, therapist and children to manage their feeding problems effectively, hence improve quality of life of parents and children.There is also scarcity of well designed randomized controlled trails and limited published literature on the usefulness of the kinesiotape for management of drooling in children with oral dysphagia, this study will be conducted in an attempt to evaluate the same. There is also a lack of comparative studies to evaluate the effectiveness of traditional oral motor therapies and kinesiotaping therapy.
speech pathologists and help them in managing drooling effectively by using the best effective therapeutic approach. This study will also add up evidence-based knowledge to existing literature
- Conditions
- Drooling
- Being tested
- kinesiotaping therapy, oral motor manipulation therapy
- Keywords
- dysphagia, drooling, kinsesiotaping therapy, manipulation therapy
- Medical subject headings
- Sialorrhea, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotaping therapyOther
Kinesiotaping is a new therapeutic technique that gives support to the lip and tongue base muscles without restricting range of motion or blood flow.
oral motor manipulation therapyOther
Manipulation therapy include tapping and massage of oral motor muscles including orbicularis oris and base of tongue.
| Study group | Role | What they receive |
|---|---|---|
| Group A kinesiotaping therapy | Experimental | Protocols mentioned in kinesiological taping i.e. 45 minutes will be pursued as with longer sessions children may tire out easily. Taping Technique for lip muscles would be used by cutting 2 "I" tapes according to the structure of lip muscles.The tape will be fixed in the center of the mouth on the upper lip, will be placed on an open mouth and a 10% tension will be given to the paper. The tape will then end at the corner of the upper lip. Kinesiotape wouldn't be placed on the lips. The second tape piece will be fixed to the center of the lower lip.The edges of the tape should overlap slightly.
The other piece of tape will be placed under chin (base of tongue) on sub mandibular triangle, inside the jaw line on the base of the tongue. A strip 1-1 ½ inch long will be cut, and then will further be cut in half such that the stretch is horizontal. It will be anchored in the middle on sub mandibular triangle. Paper off the tension to both sides. Receives: Other: kinesiotaping therapy |
| Group B Oral Motor Manipulation therapy | Active comparator | For the oral motor manipulation technique CP chair will be required to maintain the good sitting posture of children. Trunk will be in upright position with cut out lap board of the CP chair. Hips, knees and ankles would be flexed to 90 degrees. Shoulders and arms will be rested in symmetrical manner by keeping them rested in lap board and foot rest will be used to rest the feet tightly to control movement and maintain good posture. Each child would be taken for 12 weeks of therapy with three sessions per day of 15 minutes each. Oral motor manipulation like tapping protocols would be used for 45 minutes; slow, even rhythmic pressure will be applied around lip muscle and base of tongue muscle, keeping in view the comfort level of patient.
Training to do manipulation exercises will be given to the parents of children with CP at . Receives: Other: oral motor manipulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity and frequency of drooling will be measured at baseline and at the end of 24 weeks of therapy
half of both groups will be intervene for 12 weeks first and other half groups after 12 weeks, so total 24 weeks will be required for whole group to be intervene
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jan 2020
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DroolingStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romana Pervez, PhD, Principal investigator, helping hand Institute of Rehabilitation Sciences Mansehra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266626
- Sponsor's protocol ID
- 1602-PhD-004
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 12 Feb 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Psychological Outcomes of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia
- ClinicalTrials.gov ID
- NCT04266626
- Acronym / sponsor ID
- 1602-PhD-004
- Conditions
- Drooling
- Keywords
- dysphagia, drooling, kinsesiotaping therapy, manipulation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 12 Feb 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 suffering from neurological problems may have a common problem of drooling and dysphagia.There is high prevelance of neurological disorders in developing countries including Pakistan.Parents of children with disability are highly stressed and burdenised while taking care of their children.there is a need to overcome the drooling and dysphagia problems with effective interventions.
Detailed description
There is no clear consensus that which interventions are safe and effective and hard to decide about the effective intervention for drooling management. This will help the parents, therapist and children to manage their feeding problems effectively, hence improve quality of life of parents and children.There is also scarcity of well designed randomized controlled trails and limited published literature on the usefulness of the kinesiotape for management of drooling in children with oral dysphagia, this study will be conducted in an attempt to evaluate the same. There is also a lack of comparative studies to evaluate the effectiveness of traditional oral motor therapies and kinesiotaping therapy.
speech pathologists and help them in managing drooling effectively by using the best effective therapeutic approach. This study will also add up evidence-based knowledge to existing literature
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A kinesiotaping therapy | Experimental | Other: kinesiotaping therapyProtocols mentioned in kinesiological taping i.e. 45 minutes will be pursued as with longer sessions children may tire out easily. Taping Technique for lip muscles would be used by cutting 2 "I" tapes according to the structure of lip muscles.The tape will be fixed in the center of the mouth on the upper lip, will be placed on an open mouth and a 10% tension will be given to the paper. The tape will then end at the corner of the upper lip. Kinesiotape wouldn't be placed on the lips. The second tape piece will be fixed to the center of the lower lip.The edges of the tape should overlap slightly. The other piece of tape will be placed under chin (base of tongue) on sub mandibular triangle, inside the jaw line on the base of the tongue. A strip 1-1 ½ inch long will be cut, and then will further be cut in half such that the stretch is horizontal. It will be anchored in the middle on sub mandibular triangle. Paper off the tension to both sides. |
| Group B Oral Motor Manipulation therapy | Active comparator | Other: oral motor manipulation therapyFor the oral motor manipulation technique CP chair will be required to maintain the good sitting posture of children. Trunk will be in upright position with cut out lap board of the CP chair. Hips, knees and ankles would be flexed to 90 degrees. Shoulders and arms will be rested in symmetrical manner by keeping them rested in lap board and foot rest will be used to rest the feet tightly to control movement and maintain good posture. Each child would be taken for 12 weeks of therapy with three sessions per day of 15 minutes each. Oral motor manipulation like tapping protocols would be used for 45 minutes; slow, even rhythmic pressure will be applied around lip muscle and base of tongue muscle, keeping in view the comfort level of patient. Training to do manipulation exercises will be given to the parents of children with CP at . |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- • Both male and female children with different non degenerative neurological disabilities ( cerebral palsy, traumatice brain injury, childhood stroke) and having oral phase dysphagia.
Key exclusion criteria (4 listed)
- Those children who would have structural abnormality of respiratory system.
- Corrected or uncorrected cleft palate or cleft lip.
- Wounds around the lips.
- Recent surgery, and medication or on any treatment to control drooling would be excluded from the study.
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 |
|---|---|---|
| kinesiotaping therapyKinesiotaping is a new therapeutic technique that gives support to the lip and tongue base muscles without restricting range of motion or blood flow. | Other | Group A kinesiotaping therapy |
| oral motor manipulation therapyManipulation therapy include tapping and massage of oral motor muscles including orbicularis oris and base of tongue. | Other | Group B Oral Motor Manipulation therapy |
Primary outcome
severity and frequency of drooling will be measured at baseline and at the end of 24 weeks of therapy
Time frame: 24 weeks
half of both groups will be intervene for 12 weeks first and other half groups after 12 weeks, so total 24 weeks will be required for whole group to be intervene
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Drooling
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Efficacy of Targeted Pelvic Floor Muscle Exercises for Treatment of Men With Primary Post Micturition Dribbling: a Randomized Controlled Trial.
Post Micturition Dribble
Not yet recruiting
Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Cerebral Palsy (CP), Drooling
Active, not recruiting
Effect of SCS Technique on Oromotor Skills in Children With CP
Sialorrhea, Spastic Cerebral Palsy (sCP)
Not yet recruiting
Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation
Hypersialorrhea (Excessive Salivation), Psychiatric Disorders
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.
Romana Pervez, PhD principal investigator
helping hand Institute of Rehabilitation Sciences Mansehra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiotaping therapy and oral motor manipulation therapy in people with Drooling, run by Isra 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 6 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 12 Feb 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 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 Romana Pervez, PhD (03339867787, romo_virgo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity and frequency of drooling will be measured at baseline and at the end of 24 weeks of therapy (time frame: 24 weeks). 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 12 Feb 2020.