Clinical trial NCT04266626: Effectiveness of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia
Official title: Clinical and Psychological Outcomes of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drooling
Keywords: dysphagia, drooling, kinsesiotaping therapy, manipulation therapy
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: severity and frequency of drooling will be measured at baseline and at the end of 24 weeks of therapy
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Romana Pervez
state: Khyber Pakhtunkhwa
Study officials:
affiliation: helping hand Institute of Rehabilitation Sciences Mansehra
name: Romana Pervez, PhD
role: PRINCIPAL_INVESTIGATOR
References: