Effectiveness of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia

Drooling Clinical Trial

Official title:

Clinical and Psychological Outcomes of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04266626
• Other study ID #: 1602-PhD-004
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: September 2020

Study information

• Verified date: February 2020
• Source: Isra University
• Contact: Romana Pervez, PhD
• Phone: 03339867787
• Email: romo_virgo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 overcome the drooling and dysphagia problems with effective interventions.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• • 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Drooling
• Sialorrhea

Intervention

Other:
• kinesiotaping therapy
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 therapy
Manipulation therapy include tapping and massage of oral motor muscles including orbicularis oris and base of tongue.

Locations

Country	Name	City	State
Pakistan	Romana Pervez	Abbottabad	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks